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FDA PRODUCT CODE · CLASS II

OLP — Over-The-Counter Powered Light Based Laser For Acne

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4810
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K253878Shenzhen Kaiyan Medical Equipment Co., Ltd. · 510k2026-03-04
K251843Erchonia Corporation · 510k2025-09-12
K242068Ningbo Dechang Electrical Machinery Made Co.,Ltd · 510k2025-04-04
K243555Shenzhen Eyco Technology Co., Ltd. · 510k2025-02-05

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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