OLPClass II

Over-The-Counter Powered Light Based Laser For Acne

21 CFR 878.4810 / General, Plastic Surgery

OLP is the FDA product code for Over-The-Counter Powered Light Based Laser For Acne, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris". As of 2026-09-10, FDA records hold 51 510(k) clearances under this code, the most recent dated 2026-03-04, and 4 recalls.

Classification record

Product code: OLP
Device name: Over-The-Counter Powered Light Based Laser For Acne
FDA definition: The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.
Regulation: 21 CFR 878.4810
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 51
Ingested recalls: 4

Clearances, product code OLP

By decision year

51 clearances under product code OLP with a decision year between 2009 and 2026, 2016 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code OLP by decision year
Year	Clearances
2009	1
2010	3
2012	2
2013	3
2014	3
2015	3
2016	6
2017	4
2018	5
2019	2
2020	1
2021	6
2022	5
2023	3
2025	3
2026	1

Applicants with the most clearances

Product code OLP

Applicants holding the most 510(k) clearances under product code OLP
Applicant	Clearances
Nutra Luxe MD, LLC	4
LED Technologies, Inc.	3
LED Intellectual Properties LLC	2
Shenzhen Kaiyan Medical CO, Ltd.	2
Silver Bay, LLC	2
Accord Media	1
Beijing Adss Development Co., Ltd.	1
Biorenew Labs, LLC	1
Clearflash Technologies, Inc.	1
Clrs Technology Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 113 companies shown, in name order