Laserscope
San Jose, CA, US
Laserscope appears in FDA device records in San Jose, CA. FDA records list 60 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 60
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 60FDA records hold 60 510(k) clearances for Laserscope between 1985 and 2006. The busiest year on record is 1997, with 7. The most recent is 2006, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 3 |
| 1987 | 4 |
| 1988 | 4 |
| 1990 | 4 |
| 1991 | 6 |
| 1992 | 6 |
| 1993 | 3 |
| 1994 | 3 |
| 1995 | 3 |
| 1997 | 7 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent | |
| K061646 | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES | FBO | Substantially Equivalent | |
| K034011 | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent | |
| K024206 | AURA ISURGICAL LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent | |
| K020021 | LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) | GEX | Substantially Equivalent | |
| K010834 | LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES | GEX | Substantially Equivalent | |
| K010284 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | GEX | Substantially Equivalent | |
| K003765 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | GEX | Substantially Equivalent | |
| K003147 | LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) | GEX | Substantially Equivalent | |
| K990718 | ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | GEX | Substantially Equivalent | |
| K990903 | LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | GEX | Substantially Equivalent | |
| K984424 | AURA DYE LASER SYSTEM (ADLS) | GEX | Substantially Equivalent | |
| K984110 | LASERSCOPE COOLSPOT | GEX | Substantially Equivalent | |
| K972575 | 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES | GEX | Substantially Equivalent | |
| K974896 | LASERSCOPE EL LASER SYSTEM AND ACCESSORIES | GEX | Substantially Equivalent | |
| K971843 | LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES | GEX | Substantially Equivalent | |
| K971250 | LASERSCOPE MICROBEAM IV MICROMANIPULATOR | GEX | Substantially Equivalent | |
| K964818 | ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION) | GEX | Substantially Equivalent | |
| K970948 | 800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES | GEX | Substantially Equivalent | |
| K970157 | LASERSCOPE AUTOMATIC EYE PROTECTION FILTER | GEX | Substantially Equivalent | |
| K964520 | PARASCAN SCANNING DEVICE | GEX | Substantially Equivalent | |
| K964076 | LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES | GEX | Substantially Equivalent | |
| K945614 | ADD POWER FAMILY , MICRO ADDSTAT | GEX | Substantially Equivalent | |
| K951034 | AURA LASER SYSTEM | GEX | Substantially Equivalent | |
| K950662 | DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT | GEX | Substantially Equivalent | |
| K944977 | COAXIAL ENDOSTAT | GEX | Substantially Equivalent | |
| K941841 | SMARTSCAN | GEX | Substantially Equivalent | |
| K933880 | SL SERIES SURGICAL LASER SYSTEMS | GEX | Substantially Equivalent | |
| K924720 | VISIDISC KITS, SPINESCOPE | GEX | Substantially Equivalent | |
| K925130 | NESSY SURESTICK(TM)/STANDARD SURESTICK(TM) | GEI | Substantially Equivalent | |
| K924644 | ENDOSTATS, MICROSTATS, ACCUSTATS | GEX | Substantially Equivalent | |
| K913990 | KTP/532 & KTP/YAG | GEX | Substantially Equivalent | |
| K914918 | LASERSCOPE'S MICROSPOT DERMASTAT | GEX | Substantially Equivalent | |
| K921380 | LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER | GEX | Substantially Equivalent | |
| K920589 | ANGLED DELIVERY DEVICE | GEX | Substantially Equivalent | |
| K920584 | SCULPTURED ENDOSTAT | GEX | Substantially Equivalent | |
| K914518 | KTP/YAG AND KTP/YAG PLUS | GEX | Substantially Equivalent | |
| K913758 | KTP/532 AND KTP/YAG | GEX | Substantially Equivalent | |
| K914104 | ENDOSTAT | GEX | Substantially Equivalent | |
| K912538 | KTP/YAG PLUS | GEX | Substantially Equivalent | |
| K911830 | LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER | GEX | Substantially Equivalent | |
| K912023 | LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR | GCJ | Substantially Equivalent | |
| K905424 | KTP DISC KIT | GEX | Substantially Equivalent | |
| K902058 | ADD'L USE OF THE KTP/YAG SURGICAL LASER | GEX | Substantially Equivalent | |
| K901943 | KTP/532 (TM) SURGICAL LASER | GEX | Substantially Equivalent | |
| K895945 | KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE | GEX | Substantially Equivalent | |
| K896183 | KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY | GEX | Substantially Equivalent | |
| K884029 | KTP/532 SURGICAL LASER | GEX | Substantially Equivalent | |
| K882734 | KTP/YAG(TM) SURGICAL LASER | GEX | Substantially Equivalent | |
| K881788 | KTP/532(TM) SURGICAL LASER | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FBOCystourethroscope
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GCJLaparoscope, General & Plastic Surgery
- LNKLaser For Gastro-Urology Use
- EWGLaser, Ent Microsurgical Carbon-Dioxide
- LMSLaser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
- HHRLaser, Surgical, Gynecologic
- GEXPowered Laser Surgical Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain