← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OHS — Light Based Over The Counter Wrinkle Reduction

Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

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
67
510(K)/PMA CLEARANCES
510k: 67
0
RECALL ENTRIES

Recent clearances

K261407Dongguan Miqiang Technology Co., Ltd. · 510k2026-07-15
K261473Termosalud S.L. · 510k2026-07-01
K261052Guangdong Newdermo Biotech Co., Ltd. · 510k2026-06-29
K260946Guangdong Newdermo Biotech Co., Ltd. · 510k2026-06-18
K254025Shenzhen Kaiyan Medical Equipment Co., Ltd. · 510k2026-06-16
K260715The Beauty Tech Group, Ltd. · 510k2026-06-03
K260415Light Tree Ventures Europe B.V. · 510k2026-05-12
K260150NOOANCE · 510k2026-04-22

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →