FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
K Number: K990903
·
Decision Aug 27, 1999
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
60
Review Days
162
Basic Information
- Device Name
- LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
- K Number
- K990903
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LASERSCOPE
- Date Received
- March 18, 1999
- Decision Date
- August 27, 1999
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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| K Number | Device Name | ||
|---|---|---|---|
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| K061646 | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES | Jun 27, 2006 | Substantially Equivalent |
| K034011 | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES | Mar 30, 2004 | Substantially Equivalent |
| K024206 | AURA ISURGICAL LASER SYSTEM & ACCESSORIES | Nov 17, 2003 | Substantially Equivalent |
| K020021 | LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) | Jul 2, 2002 | Substantially Equivalent |
| K010834 | LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES | May 21, 2001 | Substantially Equivalent |
| K010284 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | May 1, 2001 | Substantially Equivalent |
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| K003147 | LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) | Dec 15, 2000 | Substantially Equivalent |
| K990718 | ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | Mar 8, 2000 | Substantially Equivalent |