Klox Biophotonic LumiHeal System
FDA 510(k) clearance DEN200005 · decided 2021-12-03
Clearance details
- K-number
- DEN200005
- Device name
- Klox Biophotonic LumiHeal System
- Applicant
- Klox Technlogies, Inc.
- Decision
- Unknown
- Date received
- 2020-02-04
- Decision date
- 2021-12-03
- Days to decision
- 668 days
- Clearance type
- Direct
- Product code
- QPE
- Device class
- 2
- Regulation number
- 878.4880
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Laval, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.