LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
FDA 510(k) clearance K243423 · decided 2025-01-28
Clearance details
- K-number
- K243423
- Device name
- LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
- Applicant
- Shenzhen Rainbow Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-04
- Decision date
- 2025-01-28
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- OHS
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.