← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
OLI — Fat Reducing Low Level Laser
Non-invasive reduction in fat layer for body contouring
DEVICE CLASS
Class II
REGULATION
21 CFR 878.5400
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K260688Shenzhen Kaiyan Medical Equipment Co., Ltd. · 510k2026-05-04
K260129Shenzhen Kaiyan Medical Equipment Co., Ltd. · 510k2026-04-15
K243854Contour Research, LLC · 510k2026-02-13
K252574Erchonia Corporation · 510k2025-12-15
K252786Shenzhen Suyzeko Limited. · 510k2025-12-01
K243811Erchonia Corporation · 510k2025-01-10
Related on SPEQ
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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