NS3000 Holmium Laser System
FDA 510(k) clearance K142286 · decided 2014-10-31
Clearance details
- K-number
- K142286
- Device name
- NS3000 Holmium Laser System
- Applicant
- New Star Lasers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-18
- Decision date
- 2014-10-31
- Days to decision
- 74 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
- Roseville, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscop recall (Z-1918-2015) | New Star Lasers, Inc. | 2015-06-27 |