LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
FDA 510(k) clearance K010284 · decided 2001-05-01
Clearance details
- K-number
- K010284
- Device name
- LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
- Applicant
- Laserscope
- Decision
- Substantially Equivalent
- Date received
- 2001-01-31
- Decision date
- 2001-05-01
- Days to decision
- 90 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 |
|---|---|---|
| AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and di recall (Z-1229-2011) | AMS Innovative Center - San Jose | 2011-02-14 |
| 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 |