PASCAL PHOTOCOAGULATOR, PASCAL-US
FDA 510(k) clearance K091666 · decided 2009-07-15
Clearance details
- K-number
- K091666
- Device name
- PASCAL PHOTOCOAGULATOR, PASCAL-US
- Applicant
- Optimedica Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-06-09
- Decision date
- 2009-07-15
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.