LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
FDA 510(k) clearance K032991 · decided 2004-09-14
Clearance details
- K-number
- K032991
- Device name
- LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
- Applicant
- Light Age, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-25
- Decision date
- 2004-09-14
- Days to decision
- 355 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
- Somerset, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.