Medical Device Manufacturer · US , Santa Clara , CA

Laserscope - FDA 510(k) Cleared Devices

60 submissions · 60 cleared · Since 1985

Recent clearances: GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES, LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES, GEMINI SURGICAL LASER SYSTEM & ACCESSORIES

60
Total
60
Cleared
0
Denied

Laserscope has 60 FDA 510(k) cleared general & plastic surgery devices. Based in Santa Clara, US.

Historical record: 60 cleared submissions from 1985 to 2006.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Kema Quality B.V. as regulatory consultant.

FDA 510(k) Regulatory Record - Laserscope

60 devices
1-12 of 60
Cleared Dec 01, 2006
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K062719 · GEX
General & Plastic Surgery · 80d
Cleared Jun 27, 2006
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
K061646 · FBO
Gastroenterology & Urology · 15d
Cleared Mar 30, 2004
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
K034011 · GEX
General & Plastic Surgery · 97d
Cleared Nov 17, 2003
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
K024206 · GEX
General & Plastic Surgery · 332d
Cleared Jul 02, 2002
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
K020021 · GEX
General & Plastic Surgery · 180d
Cleared May 21, 2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K010834 · GEX
General & Plastic Surgery · 62d
Cleared May 01, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K010284 · GEX
General & Plastic Surgery · 90d
Cleared Mar 06, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K003765 · GEX
General & Plastic Surgery · 90d
Cleared Dec 15, 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
K003147 · GEX
General & Plastic Surgery · 66d
Cleared Mar 08, 2000
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
K990718 · GEX
General & Plastic Surgery · 370d
Cleared Aug 27, 1999
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
K990903 · GEX
General & Plastic Surgery · 162d
Cleared Mar 05, 1999
AURA DYE LASER SYSTEM (ADLS)
K984424 · GEX
General & Plastic Surgery · 84d

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