Company ยท US
Laserscope
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2006. Name variants (Inc, Corp, punctuation) are merged.
60510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 49 |
| LNK | Laser For Gastro-Urology Use | 3 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 2 |
| HHR | Laser, Surgical, Gynecologic | 2 |
| FBO | Cystourethroscope | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| LMS | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 1, 2006 | K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES Laserscope | GEX |
| Jun 27, 2006 | K061646 | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES Laserscope | FBO |
| Mar 30, 2004 | K034011 | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES Laserscope | GEX |
| Nov 17, 2003 | K024206 | AURA ISURGICAL LASER SYSTEM & ACCESSORIES Laserscope | GEX |
| Jul 2, 2002 | K020021 | LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) Laserscope | GEX |
| May 21, 2001 | K010834 | LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES Laserscope | GEX |
| May 1, 2001 | K010284 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) Laserscope | GEX |
| Mar 6, 2001 | K003765 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) Laserscope | GEX |
| Dec 15, 2000 | K003147 | LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) Laserscope | GEX |
| Mar 8, 2000 | K990718 | ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) Laserscope | GEX |
| Aug 27, 1999 | K990903 | LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) Laserscope | GEX |
| Mar 5, 1999 | K984424 | AURA DYE LASER SYSTEM (ADLS) Laserscope | GEX |
| Dec 18, 1998 | K984110 | LASERSCOPE COOLSPOT Laserscope | GEX |
| Jul 17, 1998 | K972575 | 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES Laserscope | GEX |
| Mar 27, 1998 | K974896 | LASERSCOPE EL LASER SYSTEM AND ACCESSORIES Laserscope | GEX |
| Jul 23, 1997 | K971843 | LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES Laserscope | GEX |
| Jun 30, 1997 | K971250 | LASERSCOPE MICROBEAM IV MICROMANIPULATOR Laserscope | GEX |
| Jun 17, 1997 | K964818 | ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION) Laserscope | GEX |
| May 21, 1997 | K970948 | 800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES Laserscope | GEX |
| Apr 7, 1997 | K970157 | LASERSCOPE AUTOMATIC EYE PROTECTION FILTER Laserscope | GEX |
| Feb 10, 1997 | K964520 | PARASCAN SCANNING DEVICE Laserscope | GEX |
| Jan 8, 1997 | K964076 | LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES Laserscope | GEX |
| May 15, 1995 | K945614 | ADD POWER FAMILY , MICRO ADDSTAT Laserscope | GEX |
| Apr 13, 1995 | K951034 | AURA LASER SYSTEM Laserscope | GEX |
| Mar 10, 1995 | K950662 | DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT Laserscope | GEX |
| Nov 8, 1994 | K944977 | COAXIAL ENDOSTAT Laserscope | GEX |
| Aug 15, 1994 | K941841 | SMARTSCAN Laserscope | GEX |
| Feb 25, 1994 | K933880 | SL SERIES SURGICAL LASER SYSTEMS Laserscope | GEX |
| Oct 8, 1993 | K924720 | VISIDISC KITS, SPINESCOPE Laserscope | GEX |
| Mar 18, 1993 | K925130 | NESSY SURESTICK(TM)/STANDARD SURESTICK(TM) Laserscope | GEI |
| Feb 23, 1993 | K924644 | ENDOSTATS, MICROSTATS, ACCUSTATS Laserscope | GEX |
| Sep 2, 1992 | K913990 | KTP/532 & KTP/YAG Laserscope | GEX |
| Jul 24, 1992 | K914918 | LASERSCOPE'S MICROSPOT DERMASTAT Laserscope | GEX |
| Jun 25, 1992 | K921380 | LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER Laserscope | GEX |
| Apr 29, 1992 | K920589 | ANGLED DELIVERY DEVICE Laserscope | GEX |
| Apr 10, 1992 | K920584 | SCULPTURED ENDOSTAT Laserscope | GEX |
| Apr 2, 1992 | K914518 | KTP/YAG AND KTP/YAG PLUS Laserscope | GEX |
| Nov 20, 1991 | K913758 | KTP/532 AND KTP/YAG Laserscope | GEX |
| Sep 27, 1991 | K914104 | ENDOSTAT Laserscope | GEX |
| Sep 6, 1991 | K912538 | KTP/YAG PLUS Laserscope | GEX |
| Aug 14, 1991 | K911830 | LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER Laserscope | GEX |
| Jun 11, 1991 | K912023 | LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR Laserscope | GCJ |
| Mar 4, 1991 | K905424 | KTP DISC KIT Laserscope | GEX |
| Jun 29, 1990 | K902058 | ADD'L USE OF THE KTP/YAG SURGICAL LASER Laserscope | GEX |
| May 29, 1990 | K901943 | KTP/532 (TM) SURGICAL LASER Laserscope | GEX |
| Apr 9, 1990 | K895945 | KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE Laserscope | GEX |
| Feb 2, 1990 | K896183 | KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY Laserscope | GEX |
| Nov 25, 1988 | K884029 | KTP/532 SURGICAL LASER Laserscope | GEX |
| Sep 9, 1988 | K882734 | KTP/YAG(TM) SURGICAL LASER Laserscope | GEX |
| Jun 27, 1988 | K881788 | KTP/532(TM) SURGICAL LASER Laserscope | GEX |
Newest 50 of 60.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||