FDA Product Codes for Aesthetic Devices: Cheat Sheet (21 CFR 878.4810)
Every legally marketed medical device in the US carries a product code — a short letter code that tells you the device family, the regulation it falls under, and its review pathway. For buyers of aesthetic devices, reading these codes is the fastest way to check whether a supplier’s claim matches the equipment on the quotation. This cheat sheet lists the codes verified in the official FDA classification data (via openFDA, accessed October 2026).
21 CFR 878.4810 — the aesthetic laser & light device regulation (all 19 product codes)
| Code | Device name (official) | Typical relevance |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | Lasers: surgical, dermatology; hair removal in indications |
| ORK | Laser Assisted Lipolysis | Laser lipolysis / body contouring |
| ONG | Powered Laser Surgical Instrument With Microbeam Fractional Output | Fractional resurfacing |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | Nail fungus |
| ONO | Neurosurgical Laser With MR Thermography | Neurosurgery (not aesthetic) |
| OEL | Laser, Benign Prostatic Hyperplasia | Urology (not aesthetic) |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | Professional IPL (thermal effect) |
| ONE | Powered Light Based Non-Laser Surgical Instrument | Professional IPL |
| QHF | Energy Based Device For Treatment Of Tattoos | Q-switched / picosecond tattoo removal |
| NVK | Laser, Dental, Soft Tissue | Dental (not aesthetic) |
| LNK | Laser For Gastro-Urology Use | Gastro-urology (not aesthetic) |
| NXF | Gas, Laser Generating | Components (Class I) |
| NUV | Massager, Vacuum, Light Induced Heating | Light-based massage devices |
| OYW | Laser, Cellulite Appearance | Cellulite appearance treatments |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | Home-use acne light devices |
| OHS | Light Based Over The Counter Wrinkle Reduction | Home-use wrinkle devices |
| OHT | Light Based Over-The-Counter Hair Removal | Home-use IPL / laser hair removal |
| PKO | Transparent Patch For Use In Treatment Of Tattoos | Tattoo treatment accessory |
| QCY | Laser Absorbing Particles | Laser accessory |
Note the two facts that surprise most buyers: professional hair removal lasers are cleared here (no separate code exists), and home-use devices get their own OTC codes (OHT, OHS, OLP) — so a home-device K number is not evidence for a professional machine. Deep dives: GEX and IPL codes (ONE / ONF / OHT).
Adjacent codes outside 878.4810
| Code | Regulation | Device name (official) | Typical relevance |
|---|---|---|---|
| PAY | 878.4420 | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | Home-use RF wrinkle devices |
| ONQ | 878.4400 | Electrosurgical Coagulation For Aesthetic | Aesthetic electrocoagulation |
| PKT | 878.5400 | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | Aesthetic adipose laser devices |
| QKL | 878.5040 | Lipoaspirate Washing System For Aesthetic Body Contouring | Body contouring accessory systems |
| NFO | 882.5890 | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Aesthetic microcurrent |
| NYX | 882.5890 | Transcutaneous Electrical Stimulator With Limited Output, Aesthetic Purposes | Aesthetic microcurrent (limited output) |
A naming quirk worth knowing
There is no classification named “skin tightening”. RF and HIFU-type aesthetic devices are cleared under other classification names depending on their technology and intended use. If a supplier cannot tell you which product code and classification name their device was cleared under, that is the conversation to have before the price conversation.
How to keep this table honest
- Codes are occasionally added or modified. Re-verify at openFDA or the product classification database before relying on a specific code.
- The code identifies the device family; the indications for use in each 510(k) define what was actually cleared.
- Registration and listing entries let you match a supplier’s legal entity to a listed device (registration & listing database).
Using the codes to verify a live supplier claim? Follow the 10-minute verification guide. For the process behind a clearance, see 510(k) for aesthetic lasers.
Last updated: October 11, 2026. Product codes and regulatory references were verified against official FDA sources (openFDA / accessdata.fda.gov) on this date. This page provides general purchasing information, not legal advice; regulations change, so confirm requirements at the time you buy.
Working with multiple suppliers and want a second pair of eyes on specifications and market availability? contact the LEIJEX team or review our manufacturing and quality system.