The documents behind these four pens treat the cartridge in three different ways, since the SkinPen Precision manual and the FDA clearance for the Elite describe a check on the cartridge, the SkinStylus instructions write the rule into the text and the warranty, and the FDA 510(k) summaries for Rejuvapen NXT and MicroPen EVO, read in full on September 23 and again on September 24, 2026, describe a single-use cartridge with a seal on the cartridge or a separate disposable sheath and do not describe a lock-out or authentication feature. Each rule below carries its document type and reading date, because a lock in a manual and a condition in a warranty call for different questions to the supplier. Cartridge cost is a separate question, covered for SkinPen and two other brands in SkinPen, Dr. Pen and Dermapen compared on cartridge cost.
Where each pen's documents place the cartridge rule
For SkinPen the cartridge rule sits in the maker's Precision manual and in the FDA clearance for the Elite, for SkinStylus SteriLock MicroSystem in instructions for use and warranty terms, and for Rejuvapen NXT and MicroPen EVO in the FDA 510(k) summaries read for this page, which describe a single-use cartridge and do not describe a lock-out. The table gives each document's type in the second column; read the second column before the fourth, because a lock described in a manufacturer's manual is a design statement and a purchase condition in a warranty is a contract term.
| pen | document and type | what it says about the cartridge | lock-out or authentication check described | read on |
|---|---|---|---|---|
| SkinPen Precision | SkinPen Precision user manual (manufacturer's instructions) | "designed for single use, with a lock-out feature prohibiting re-installation"; "Proprietary needle cartridge." | Yes, a lock-out feature that prohibits re-installation | September 18 and 23, 2026 |
| SkinPen Precision Elite | FDA 510(k) clearance K241400 | "Cartridges now can be authenticated with an NFC chip."; "verify that the cartridge is not being re-used" | Yes, an NFC chip for authentication and an LCD check against re-use | September 18 and 24, 2026 |
| Rejuvapen NXT | FDA 510(k) summary K192138 | "Single Use micro needle cartridge"; "safety membrane (seal)" | Not described; summary read in full three times | September 23 and 24, 2026 |
| MicroPen EVO | FDA 510(k) summaries K203144 and K212558 | "a sterile, single use microneedling cartridge"; "MicroSleeve Sheath (Disposable)" | Not described; both summaries read in full three times | September 23 and 24, 2026 |
| SkinStylus SteriLock MicroSystem | FDA 510(k) summary K200044 | "a disposable, single use cartridge containing an array of microneedles" | Not described; summary read in full three times | September 23 and 24, 2026 |
| SkinStylus SteriLock MicroSystem | Instructions for use that Hydrafacial LLC links from its electronic IFU page (P/N 1900194-C, rev. 05/12/2026) | "Use ONLY original safety needle cartridges for the device"; "authorized accessories"; warranty tied to purchase from Hydrafacial LLC or its authorized distributor(s) | Not established; instructions read in part | September 23, 2026 |
If Rejuvapen NXT or MicroPen EVO is on your shortlist, ask the supplier for its instructions for use with document number and revision, and read the cartridge and warranty sections before you sign.
What the SkinPen documents build into the cartridge
The SkinPen Precision manual describes a cartridge designed for single use, with a lock-out feature that prohibits re-installation after use (read September 18, 2026), and the same manual calls it a proprietary needle cartridge (read September 23, 2026). In the manual's words, a cartridge that comes off the handpiece "cannot be re-installed" on the device once removed (read September 20, 2026), so a removed cartridge is replaced, never refitted. The SkinPen Precision user manual, read in full on September 23, 2026, also tells the user not to use any equipment "not designed specifically for" the SkinPen Precision and gives interference with the device's operation as the reason. The clause speaks of equipment in general, so ask the supplier how it applies before you order a cartridge the maker does not list for this pen.
For the Elite system, the FDA 510(k) clearance K241400 lists an NFC chip for checking that a cartridge is authentic (read September 18 and 24, 2026), where the earlier SkinPen Precision is listed with a "Manual lock out", and says the LCD screen lets users "verify that the cartridge is not being re-used" (both read September 24, 2026). The two cartridges also carry different numbers, part number F5SP021 in the Precision manual and catalog number F5SP388 in the FDA device database record for the Elite cartridge (both read September 18, 2026). Put the part number on the purchase order next to the handpiece model you own, since the documents list the two cartridges separately, and ask the supplier to confirm in writing which handpiece the quoted cartridge fits.
The warranty in the Precision manual runs "One year under normal use after its original purchase" (read September 20, 2026). Read in full on September 23, 2026, the warranty section covers the original purchaser only and excludes neglect, alteration, misuse, "installation by anyone other than factory authorized personnel" and disassembly or repair without the maker's consent. A separate passage on electromagnetic compatibility warns against accessories other than those specified or provided by the manufacturer, which is a technical warning and not a warranty term (read September 23, 2026). If a supplier tells you the SkinPen warranty depends on the cartridge, ask to see the clause, and see warranty terms outside the authorized channel.
What four FDA summaries describe in place of a lock
Four FDA 510(k) summaries for Rejuvapen NXT, MicroPen EVO and SkinStylus SteriLock MicroSystem, read in full on September 23 and again twice on September 24, 2026, describe a single-use cartridge and do not describe a lock-out or authentication feature, while the SkinPen Precision Elite clearance K241400 (read September 18, 2026) lists an NFC chip for checking that a cartridge is authentic.
The FDA 510(k) summary for Rejuvapen NXT, K192138, read in full on September 23 and twice on September 24, 2026, describes a cartridge that "contains a safety membrane (seal) that was tested under laboratory conditions" and does not describe a lock-out or authentication feature. The same summary compares the pen with its predicate, the SkinPen Precision System, and says of the two that "Both use treatment tips that are disposable and for single use only." Single use is written there as intended use, a rule for the operator, and what the summary describes in place of a lock is the seal. Ask the supplier which document describes how single use is enforced on this pen.
The FDA 510(k) summary for MicroPen EVO, K203144, read in full on September 23 and twice on September 24, 2026, describes a sterile, single-use cartridge with a disposable MicroSleeve sheath as the cross-contamination barrier and does not describe a lock-out or authentication feature. Its fluid ingress testing covered the sheath together with the cartridge and reports "effective protection against the ingress of fluid". The later FDA 510(k) summary for MicroPen EVO, K212558, read in full on September 23 and twice on September 24, 2026, describes "a sterile, single use microneedling cartridge" with the same disposable sheath and does not describe a lock-out or authentication feature. Because both summaries name the disposable sheath alongside the cartridge, ask whether the supply agreement covers the sheath as well as the cartridge.
The FDA 510(k) summary for SkinStylus SteriLock MicroSystem, K200044, read in full on September 23 and twice on September 24, 2026, describes "a disposable, single use cartridge containing an array of microneedles" and does not describe a lock-out or authentication feature. Protection against cross-contamination is given as "Cartridge design and intermediate disinfected handpiece and nosecone", and the nosecone separates the motor from the cartridge so fluid does not enter the body of the handpiece. Two GUDID records for SkinStylus cartridges, read the same day, list K231073 and K253002 next to K200044; ask the supplier what those two submissions say about the cartridge. A lock-out missing from one summary is a statement about that document, and it does not carry over to the device.
What the SkinStylus instructions ask of the clinic
The SkinStylus SteriLock MicroSystem instructions for use that Hydrafacial LLC links from its electronic IFU page tell the user to use only original safety needle cartridges and to run the system only with authorized accessories (read September 23, 2026). The same document describes the cartridge being threaded clockwise onto the nosecone until secure, then turned the other way to remove it for the sharps container. The electronic IFU page of Hydrafacial LLC lists three versions of these instructions, marked MD, NMD and EU NMD; the MD version, P/N 1900194-C, rev. 05/12/2026, was read, and only in part. In these instructions the cartridge rule is addressed to the user, so ask Hydrafacial LLC whether the device itself checks the cartridge.
The warranty in the same instructions is limited to the original purchaser and applies, in the document's words, "ONLY when purchases from Hydrafacial LLC or its authorized distributor(s)", and it excludes damage from "Use with unauthorized accessories" (read September 23, 2026). The condition therefore attaches to the channel the system was bought through as well as to what is used with it. Before you buy a SkinStylus system from a reseller, get written confirmation that the seller is an authorized distributor of Hydrafacial LLC, because under these instructions the warranty depends on that status.
Who files the cartridge records in the FDA device database
The company named on a pen's 510(k) and the company that files its cartridge record in the FDA's GUDID database are not always the same, since the SkinStylus clearance K200044 names Esthetic Education LLC as applicant while the SkinStylus cartridge records read on September 23, 2026 name Hydrafacial LLC. For SkinPen, the GUDID record for the SkinPen Precision cartridge REF014, catalog number F5SP021, is filed by Bellus Medical (read September 18, 2026). For Rejuvapen NXT, the 510(k) applicant is Refine USA, LLC, and GUDID searches for "rejuvapen" and "refine usa" return one record under Refine Usa, LLC, model NXT Model 102 (read September 23, 2026), so ask the supplier for the registry identifier of the ISO Tips or EXCEL Tip you are quoted.
MicroPen EVO has two cartridge records. The record filed by ECLIPSE under catalog number 50EVO2000-010 is linked to K203144 and K212558, both issued to Eclipse MedCorp, and the record filed by Bellus Medical under model F5SP223 shows "Not Available/Not Released" as its premarket submission number (all read September 23, 2026). Bellus Medical is thus the filer on the SkinPen REF014 record (read September 18, 2026) and on one of the MicroPen EVO records (read September 23, 2026), which this page reports as a database entry and nothing more. When a supplier quotes a cartridge, match the company name and the catalog or model number on the box against the record, and ask which of the two MicroPen EVO references you are being sold. Prices are outside this page; see cartridge cost across microneedling pens.
What each brand's sign-up path asks of a practice
SkinPen's page for providers says the device is only available to physician-directed practices (read September 18 and 23, 2026), while the provider pages and forms of Rejuvapen NXT, MicroPen EVO and SkinStylus, read on September 23, 2026, lead to sales and training contacts. The SkinPen Precision manual adds the line "Federal law restricts this device to sale by or on the order of a physician" (read September 18, 2026). Neither the providers page nor the Crown Aesthetics products page shows a price for the device or the cartridges, and the products page points practices to "Become A Provider" (providers page read September 20 and 23, 2026; products page read September 18 and 23, 2026). For SkinPen the entry condition is published, so your question to the supplier is how that status carries over to cartridge reorders; see also how to order a SkinPen and who can buy professional aesthetic consumables in the US.
The Rejuvapen NXT providers page offers "Live online training included at no charge", and the brand's home page carries a provider finder and a contact form (read September 23, 2026). For MicroPen EVO, crownaesthetics.com/become-a-provider/ redirects to a sign-up page whose form asks for a "Practice Specialty" and lists SkinPen Precision Elite, SkinPen Precision and MicroPen EVO. The provider page on eclipsemed.com, the domain of the 510(k) applicant, promises "ongoing training and support" (both read September 23, 2026); ask Eclipse whether that program covers MicroPen EVO.
On skinstylus.com the "BECOME A PROVIDER" button opens the same form as "TALK WITH SALES". That form asks for a profession, with the options Doctor, Nurse, PA/NP, Aesthetician, Cosmetologist, Student and Other, lists "Training" among inquiry topics, asks whether the inquirer is a Hydrafacial customer, and directs system owners who need service, repair or supplies away from the sales form (read September 23, 2026). Before the demo, ask each brand in writing whether training or a license is a condition of purchase, and who may buy cartridges on what terms.
Which parts the documents say a clinic keeps
Beyond the cartridge, the documents read for this page name parts a clinic keeps, such as the SkinStylus nosecone, which K200044 says is autoclaved or disinfected after every use, the MicroPen EVO handpiece, which K203144 describes as reusable, and the SkinPen Precision pen, which its manual says to clean after each procedure (both clearances read September 23, 2026; manual read September 20, 2026). K203144 also gives the MicroPen EVO handpiece a lithium-ion battery. The SkinPen Precision manual lists the handpiece as part F5SP005, the charging base as F5SP006 and the power supply as F5SP007, names Sani-Cloth HB wipes or another suitable disinfection method for that cleaning, and states that there are no user serviceable parts (read September 20, 2026). These are the parts that stay in the clinic when the cartridge supply changes, so count their reprocessing and replacement terms in the offer. For Rejuvapen NXT, ask which document states how the handheld unit is reprocessed between treatments.
Three third-party seller pages were opened on September 23, 2026. An Integrity PRP page for replacement cartridges says they are "also compatible with other microneedling devices"; an ended eBay auction offered SkinStylus BioLock 2 cartridges, a line other than SteriLock; and an accio.com page for "evo micropen" listed suppliers in China. Ask any third-party seller to name in writing the devices its cartridge fits. Fit is outside this page; see which cartridge fits which device.
Before you order a pen, ask for the document that states where its cartridges may come from and what the warranty excludes. You can request a quote and ask for the cartridge source to be named in it.
FAQ
Does the name SteriLock describe a cartridge lock?
Not in FDA clearance K200044, where the word appears only as part of the trade name SkinStylus SteriLock MicroSystem and is not tied to any locking mechanism (three full readings, September 23 and 24, 2026). Treat the name as a name and ask the supplier for the clause that describes any check on the cartridge.
How long is the SkinStylus warranty?
Published SkinStylus sources give two different figures, since the SkinStylus instructions for use linked by Hydrafacial LLC and the skinstylus.com home page state one year (read September 23, 2026), while the skinstylus.com MicroSystem page shows a "2-YEAR WARRANTY" label (read September 24, 2026). Ask which parts that label covers and from which date it runs. Under the instructions, coverage belongs to the first buyer and depends on buying from Hydrafacial LLC or a distributor it has authorized. Have the period and the channel written into the quote.
Do these documents give a shelf life for the cartridge?
Three of them do, and each attaches the period differently, since the SkinPen Precision manual counts two years from the sterilization date (read September 18, 2026), the MicroPen EVO clearance K203144 gives two years for the cartridge, and the Rejuvapen NXT clearance K192138 gives two years for the handheld unit and the cartridge together (both clearances read September 23, 2026). For the Elite cartridge, get the shelf life in writing from the supplier. With one cartridge source, that period caps the stock you can hold, so ask for the sterilization date on each lot before a bulk order.