FOX 810, FOX 980
FDA 510(k) clearance K220531 · decided 2022-09-01
Clearance details
- K-number
- K220531
- Device name
- FOX 810, FOX 980
- Applicant
- A.R.C Laser GmbH
- Decision
- Substantially Equivalent
- Date received
- 2022-02-24
- Decision date
- 2022-09-01
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Nurnberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.