LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
FDA 510(k) clearance K082721 · decided 2008-10-28
Clearance details
- K-number
- K082721
- Device name
- LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
- Applicant
- Photo Medex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-17
- Decision date
- 2008-10-28
- Days to decision
- 41 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
- Montgomeryville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA** recall (Z-0005-2014) | PhotoMedex, Inc. | 2013-10-01 |