Sentient Manufacturing Laser Fiber
FDA 510(k) clearance K213554 · decided 2022-02-02
Clearance details
- K-number
- K213554
- Device name
- Sentient Manufacturing Laser Fiber
- Applicant
- Sentient Manufacturing , LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-11-08
- Decision date
- 2022-02-02
- Days to decision
- 86 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
- Park City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.