← Back to catalogue
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
FDA 510(k)Class II (US FDA 510(k))
510(k) K253878
Identifiers
- 510(k) Number
- K253878 FDA 510(k)
- FDA Product Code
- OLP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) by Shenzhen Kaiyan Medical Equipment Co, . Ltd — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253878 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
- FDA Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
Sources (1)
- FDA 510(k) K253878 24 fields · synced Jun 18, 2026