GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
FDA 510(k) clearance K062719 · decided 2006-12-01
Clearance details
- K-number
- K062719
- Device name
- GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
- Applicant
- Laserscope
- Decision
- Substantially Equivalent
- Date received
- 2006-09-12
- Decision date
- 2006-12-01
- Days to decision
- 80 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
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Ma recall (Z-0700-2013) | AMS Innovative Center - San Jose | 2013-01-22 |
| GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical S recall (Z-2502-2010) | AMS Innovative Center - San Jose | 2010-09-25 |
| GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0 recall (Z-0130-2008) | AMS Innovative Center - San Jose | 2008-03-20 |
| American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 001 recall (Z-0131-2008) | AMS Innovative Center - San Jose | 2008-02-26 |