Multifrax Laser System
FDA 510(k) clearance K213332 · decided 2022-06-03
Clearance details
- K-number
- K213332
- Device name
- Multifrax Laser System
- Applicant
- Paradigm Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-10-06
- Decision date
- 2022-06-03
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- ONG
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.