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Device types and FDA codes

FDA files every device decision under a three-letter product code. These are the 8 codes this site covers: 7 consumer-device codes and 1 prescription code. They aren't every code a beauty device could be filed under.

Codes this site covers. "Device type" is our label for the grouping; FDA's own name for each code is beside it.
Device type (our words)	Code	FDA device name	Records
LED and light devices for wrinkles	OHS	Light Based Over The Counter Wrinkle Reduction	163
LED and light devices for acne	OLP	Over-The-Counter Powered Light Based Laser For Acne	51
Heat devices for acne	OZC	Over The Counter Thermal Treatment For Acne.	1
Laser and IPL hair removal (mostly over-the-counter; 1 record says prescription use)	OHT	Light Based Over-The-Counter Hair Removal	165
Laser and LED hair-growth caps, helmets and combs (1 record says prescription use)	OAP	Laser, Comb, Hair	114
At-home radiofrequency (RF) wrinkle devices	PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	12
Electrical stimulation for aesthetic use (microcurrent and EMS)	NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	82
Powered microneedling devices (prescription) Prescription	QAI	Powered Microneedle Device	26

Some devices are filed under more than one code. openFDA lists each record under its primary code only, so a mask cleared for both wrinkles and acne may appear in just one list. FDA's database page for the record shows any additional code. Within a code, individual records can list uses that differ from the code's name.

Codes we left out

Clinic and surgical lasers and light systems (codes GEX, ONF, ONE). These codes don't separate home devices from professional ones, so we can't list them without guessing.
Infrared lamps and low-level lasers for pain (codes ILY, IOB, NHN). Some red-light panels are filed here, but the cleared use is heating or pain relief, not skin or hair.
Body contouring and cellulite devices (codes PBX, NUV, OYW, PKT), which are professional systems.

Heat devices for acne

Records FDA files under its code for over-the-counter thermal acne treatment: handheld devices that apply heat to a blemish. 1 record in code OZC, so it's listed here rather than on its own page.

What FDA's code OZC covers

FDA device name: “Over The Counter Thermal Treatment For Acne.”
FDA definition: “For the treatment of mild to moderate inflammatory acne.”
Physical state: “In addition to the device, there may be batteries, re-charger, USB cable”
Technical method: “Deliver heat to acne to kill propionibacterium acne virus”
Target area: “Acne/pimples”
Regulation: 21 CFR 890.5740: “A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces.” FDA places this acne code under its powered heating pad regulation.
Device class: Class II

Quoted from FDA's Product Classification database entry for OZC, checked October 12, 2026.

510(k) clearedFeb 29, 2012

CLEANE / CLEANE POP

510(k) number: K111341
Applicant: Medicon Co., Ltd.
Product code: OZC: Over The Counter Thermal Treatment For Acne.
Regulation: 21 CFR 890.5740, Class II
FDA decision: Substantially Equivalent (SESE)
Received: May 12, 2011

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 5.

FDA database record FDA document (PDF)