LPI ML 100/532 AND ML 532 SURGICAL LASER
FDA 510(k) clearance K915631 · decided 1992-06-15
Clearance details
- K-number
- K915631
- Device name
- LPI ML 100/532 AND ML 532 SURGICAL LASER
- Applicant
- Laser Photonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-17
- Decision date
- 1992-06-15
- Days to decision
- 181 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
- Orlando, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.