SL3
FDA 510(k) clearance K102639 · decided 2010-12-01
Clearance details
- K-number
- K102639
- Device name
- SL3
- Applicant
- Discus Dental, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-09-14
- Decision date
- 2010-12-01
- Days to decision
- 78 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
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culv recall (Z-1186-2013) | Discus Dental LLC | 2013-04-29 |