COMPAC A, ELITE A, ELITE A PLUS, SURGICA A
FDA 510(k) clearance K913569 · decided 1991-10-17
Clearance details
- K-number
- K913569
- Device name
- COMPAC A, ELITE A, ELITE A PLUS, SURGICA A
- Applicant
- Hgm Medical Laser Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-09
- Decision date
- 1991-10-17
- Days to decision
- 69 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
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before N recall (Z-0545-06) | Lumenis Inc. | 2006-03-02 |