Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
FDA 510(k) clearance K210545 · decided 2022-05-20
Clearance details
- K-number
- K210545
- Device name
- Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
- Applicant
- Marci Beauty, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-25
- Decision date
- 2022-05-20
- Days to decision
- 449 days
- Clearance type
- Traditional
- Product code
- OLP
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Las Vegas, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.