Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

60 results for "Laserscope"
1–24 of 60
Search insights Median review: 90d Cleared: 100% Top manufacturer: Laserscope Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2006
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K062719 · GEX
Laserscope
General & Plastic Surgery · 80d
Cleared Jun 27, 2006
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
K061646 · FBO
Laserscope
Gastroenterology & Urology · 15d
Cleared Mar 30, 2004
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
K034011 · GEX
Laserscope
General & Plastic Surgery · 97d
Cleared Nov 17, 2003
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
K024206 · GEX
Laserscope
General & Plastic Surgery · 332d
Cleared Jul 02, 2002
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
K020021 · GEX
Laserscope
General & Plastic Surgery · 180d
Cleared May 21, 2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K010834 · GEX
Laserscope
General & Plastic Surgery · 62d
Cleared May 01, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K010284 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Mar 06, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K003765 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Dec 15, 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
K003147 · GEX
Laserscope
General & Plastic Surgery · 66d
Cleared Mar 08, 2000
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
K990718 · GEX
Laserscope
General & Plastic Surgery · 370d
Cleared Aug 27, 1999
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
K990903 · GEX
Laserscope
General & Plastic Surgery · 162d
Cleared Mar 05, 1999
AURA DYE LASER SYSTEM (ADLS)
K984424 · GEX
Laserscope
General & Plastic Surgery · 84d
Cleared Dec 18, 1998
LASERSCOPE COOLSPOT
K984110 · GEX
Laserscope
General & Plastic Surgery · 31d
Cleared Jul 17, 1998
800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED...
K972575 · GEX
Laserscope
General & Plastic Surgery · 372d
Cleared Mar 27, 1998
LASERSCOPE EL LASER SYSTEM AND ACCESSORIES
K974896 · GEX
Laserscope
General & Plastic Surgery · 86d
Cleared Jul 23, 1997
LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES
K971843 · GEX
Laserscope
General & Plastic Surgery · 70d
Cleared Jun 30, 1997
LASERSCOPE MICROBEAM IV MICROMANIPULATOR
K971250 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Jun 17, 1997
ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION)
K964818 · GEX
Laserscope
General & Plastic Surgery · 200d
Cleared May 21, 1997
800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES
K970948 · GEX
Laserscope
General & Plastic Surgery · 68d
Cleared Apr 07, 1997
LASERSCOPE AUTOMATIC EYE PROTECTION FILTER
K970157 · GEX
Laserscope
General & Plastic Surgery · 81d
Cleared Feb 10, 1997
PARASCAN SCANNING DEVICE
K964520 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Jan 08, 1997
LASERSCOPE ERBIUM
K964076 · GEX
Laserscope
General & Plastic Surgery · 89d
Cleared May 15, 1995
ADD POWER FAMILY , MICRO ADDSTAT
K945614 · GEX
Laserscope
General & Plastic Surgery · 181d
Cleared Apr 13, 1995
AURA LASER SYSTEM
K951034 · GEX
Laserscope
General & Plastic Surgery · 38d