K253878
- 510(k) number
- K253878
- Device name
- LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd. CN
- Product code
- OLP — Over-The-Counter Powered Light Based Laser For Acne
- Decision date
- 2026-03-04
- Date received
- 2025-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K253878.pdf
Official FDA record: K253878
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.