Company ยท US
Sharplan Lasers, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1997. Name variants (Inc, Corp, punctuation) are merged.
78510(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 | 66 |
| LNK | Laser For Gastro-Urology Use | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 |
| LFL | Instrument, Ultrasonic Surgical | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| MGI | Aspirator, Ultrasonic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 4, 1997 | K973354 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) Sharplan Lasers, Inc. | GEX |
| Aug 27, 1997 | K972099 | SHARPLAN EPITOUCH RUBY LASER SYSTEM Sharplan Lasers, Inc. | GEX |
| Aug 18, 1997 | K971874 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) Sharplan Lasers, Inc. | GEX |
| Jul 23, 1997 | K971648 | SHARPLAN ERBIUM: YAG LASER (4020) Sharplan Lasers, Inc. | GEX |
| Jul 18, 1997 | K971743 | SHARPLAN CO2 SURGICAL LASER SYSTEM Sharplan Lasers, Inc. | GEX |
| Mar 7, 1997 | K962446 | SHARPLAN RUBY LASER SYSTEM Sharplan Lasers, Inc. | GEX |
| Nov 5, 1996 | K963229 | SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS Sharplan Lasers, Inc. | GEX |
| Nov 1, 1996 | K961935 | SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER Sharplan Lasers, Inc. | GEX |
| Aug 21, 1996 | K962974 | SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) Sharplan Lasers, Inc. | GEX |
| Jun 18, 1996 | K961279 | SHARPLAN LASERS, INC. RUBY LASER SYSTEM Sharplan Lasers, Inc. | GEX |
| May 10, 1996 | K960820 | SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER Sharplan Lasers, Inc. | GEX |
| Apr 29, 1996 | K960040 | SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE Sharplan Lasers, Inc. | LFL |
| Apr 26, 1996 | K960521 | SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER Sharplan Lasers, Inc. | GEX |
| Feb 27, 1996 | K955621 | SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER Sharplan Lasers, Inc. | GEX |
| Nov 16, 1995 | K952277 | SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM Sharplan Lasers, Inc. | GEX |
| Nov 14, 1995 | K953794 | SHARPLAN LASERS, INC. SURGICAL DIODE LASER Sharplan Lasers, Inc. | GEX |
| Jun 12, 1995 | K951165 | SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM Sharplan Lasers, Inc. | GEX |
| Jun 1, 1995 | K951204 | SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR Sharplan Lasers, Inc. | GEX |
| May 24, 1995 | K945796 | SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM Sharplan Lasers, Inc. | ITX |
| Apr 6, 1995 | K950725 | SHARPLAN MODEL 1015 CO2 LASER Sharplan Lasers, Inc. | GEX |
| Aug 25, 1994 | K933918 | SHARPLAN MODEL 1080S CO2 SURGICAL LASER Sharplan Lasers, Inc. | GEX |
| Aug 23, 1994 | K942740 | SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEM Sharplan Lasers, Inc. | GCJ |
| Jun 30, 1994 | K941312 | SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN Sharplan Lasers, Inc. | GEX |
| May 17, 1994 | K936109 | SHARPLAN MODEL 1120 CO2 SURGICAL LASER Sharplan Lasers, Inc. | GEX |
| May 17, 1994 | K935563 | SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIES Sharplan Lasers, Inc. | GEX |
| Mar 9, 1994 | K926543 | SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 60 Sharplan Lasers, Inc. | GEX |
| Feb 23, 1994 | K923605 | MODIFIED SHARPLAN 1041 Sharplan Lasers, Inc. | GEX |
| Feb 7, 1994 | K934097 | I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA Sharplan Lasers, Inc. | GCJ |
| Nov 2, 1993 | K930582 | SHARPLAN SHARPLASE LATERAL ND:YAG FIBER Sharplan Lasers, Inc. | GEX |
| Sep 23, 1993 | K931978 | SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM Sharplan Lasers, Inc. | GEX |
| Aug 2, 1993 | K920865 | SHARPLAN 2100,3000,SHARPLASER 65, 40 Sharplan Lasers, Inc. | GEX |
| Dec 24, 1992 | K923855 | SHARPULSE Sharplan Lasers, Inc. | GEX |
| Jun 8, 1992 | K921146 | SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 Sharplan Lasers, Inc. | GEX |
| May 13, 1992 | K921596 | SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE Sharplan Lasers, Inc. | GEX |
| Mar 27, 1992 | K913848 | SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR Sharplan Lasers, Inc. | MGI |
| Mar 11, 1992 | K914455 | SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIES Sharplan Lasers, Inc. | GEX |
| Dec 6, 1991 | K914089 | SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG Sharplan Lasers, Inc. | GEX |
| Sep 6, 1991 | K913037 | SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS Sharplan Lasers, Inc. | GEX |
| Aug 29, 1991 | K912792 | SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER Sharplan Lasers, Inc. | GEX |
| Apr 8, 1991 | K910051 | SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65 Sharplan Lasers, Inc. | GEX |
| Oct 11, 1990 | K903230 | SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075 Sharplan Lasers, Inc. | GEX |
| Apr 10, 1990 | K900345 | SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY Sharplan Lasers, Inc. | GEX |
| Apr 4, 1990 | K900346 | SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY Sharplan Lasers, Inc. | GEX |
| Mar 27, 1990 | K900592 | SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASER Sharplan Lasers, Inc. | GEX |
| Mar 22, 1990 | K900076 | SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR Sharplan Lasers, Inc. | GEX |
| Mar 19, 1990 | K900153 | SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM Sharplan Lasers, Inc. | GEX |
| Mar 6, 1990 | K900077 | SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM Sharplan Lasers, Inc. | GEX |
| Feb 16, 1990 | K896762 | SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY Sharplan Lasers, Inc. | GEX |
| Jan 24, 1990 | K896847 | SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEM Sharplan Lasers, Inc. | GEX |
| Oct 5, 1989 | K895746 | SHARPLAN MODEL 710 MICROSPOT Sharplan Lasers, Inc. | GEX |
Newest 50 of 78.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||