LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)— 510(k) K253878
Substantially EquivalentShenzhen Kaiyan Medical Equipment Co., Ltd.
FDA 510(k) clearance K253878 for LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001), Substantially Equivalent on 2026-03-04. Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Product code
- Code OLP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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More clearances from Shenzhen Kaiyan Medical Equipment Co., Ltd.
view allAdverse events under product code OLP
product code OLP- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.