Panels › Obstetrics/Gynecology › Product code HHR · Class 2
Laser, Surgical, Gynecologic
Regulation 884.4550
0510(k)s in 12 months (48 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HHR
| Company | 510(k)s | Recalls |
|---|---|---|
| Cooper Lasersonics, Inc. | 4 | 0 |
| Directed Energy, Inc. | 4 | 0 |
| Endo Lase, Inc. | 3 | 0 |
| Laser Media | 2 | 0 |
| Laserscope | 2 | 0 |
| Merrimack Laboratories | 2 | 0 |
| Minnesota Laser Corp. | 2 | 0 |
| Photon Sources | 2 | 0 |
| Surgical Laser Technologies, Inc. | 2 | 0 |
| Advanced Biomedical Instruments | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 1989 | K881507 | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES Hgm Medical Laser Systems, Inc. | HHR |
| Aug 22, 1988 | K871875 | MODEL 5050 SURGILASER FOR OB-GYN USE Lasermatic, Inc. | HHR |
| Aug 5, 1988 | K875314 | GL-35 COLPOSCOPIC LASER SYSTEM Laser Engineering, Inc. | HHR |
| Jun 23, 1988 | K874615 | LASER CANNISTER FILTER Medical Marketing, Inc. | HHR |
| Jun 1, 1988 | K880591 | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE Laser Peripherals, LLC | HHR |
| May 31, 1988 | K880930 | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE Copper Lasersonics, Inc. | HHR |
| May 25, 1988 | K880991 | LASER OPTICAL CATHETER SYSTEM Medline Industries, Inc. | HHR |
| Mar 24, 1988 | K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION Cooper Lasersonics, Inc. | HHR |
| Mar 14, 1988 | K874837 | KTP/532 LASER FOR OB-GYN USE Laserscope | HHR |
| Feb 22, 1988 | K875078 | HERACURE LS 500 W.C. Heraeus GmbH, DE | HHR |
| Feb 2, 1988 | K872709 | MODEL 20-C, RL-20A/U, OB-10A/U Directed Energy, Inc. | HHR |
| Feb 2, 1988 | K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN Directed Energy, Inc. | HHR |
| Jan 28, 1988 | K864946 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE Bio Quantum Technologies, Inc. | HHR |
| Dec 30, 1987 | K872352 | FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA Laser Media | HHR |
| Dec 14, 1987 | K872254 | SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL Surgical Laser Technologies, Inc. | HHR |
| Nov 16, 1987 | K871579 | MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE Sharplan Lasers, Inc. | HHR |
| Oct 6, 1987 | K872253 | CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA Surgical Laser Technologies, Inc. | HHR |
| Jul 16, 1987 | K871220 | MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. Cooper Lasersonics, Inc. | HHR |
| Mar 5, 1987 | K870046 | DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET Tti Medical | HHR |
| Mar 5, 1987 | K864378 | CO2 LASER MICROMANIPULATOR Transamerican Technologies Intl. | HHR |
| Mar 2, 1987 | K863221 | OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN Laserscope | HHR |
| Nov 24, 1986 | K863361 | MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA Cooper Lasersonics, Inc. | HHR |
| Oct 27, 1986 | K862861 | SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE Directed Energy, Inc. | HHR |
| Oct 6, 1986 | K863520 | CO2 LASER MICROMANIPULATOR Laser Spectrum, Inc. | HHR |
| Sep 25, 1986 | K862444 | FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA Laser Media | HHR |
| Aug 20, 1986 | K862228 | CABOT LASER LAPAROSCOPY ACCESSORY SET Cabot Medical Corp. | HHR |
| Aug 19, 1986 | K862227 | MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN Hgm, Inc. | HHR |
| Aug 12, 1986 | K862456 | ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION Cooper Lasersonics, Inc. | HHR |
| Aug 11, 1986 | K861845 | MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE Directed Energy, Inc. | HHR |
| Feb 21, 1986 | K855093 | MEDILAS 2 ND:YAG LASER SURGERY SYSTEM Endo Lase, Inc. | HHR |
| Feb 21, 1986 | K853903 | ENDO-LASE CD40 CO2 FOR GYNECOLOGY Endo Lase, Inc. | HHR |
| Feb 21, 1986 | K853876 | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY Endo Lase, Inc. | HHR |
| Feb 12, 1986 | K860329 | FYODOROV RADIAL KERATOTOMY MARKER SET Med-Tech Develoment Corp. | HHR |
| Feb 7, 1986 | K854470 | PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI Minnesota Laser Corp. | HHR |
| Feb 4, 1986 | K854361 | CO2 LASER LAPAROSCOPE SYSTEM Richard Wolf Medical Instruments Corp. | HHR |
| Nov 12, 1985 | K851425 | MODEL J25-25 WATT CO2 LASER Britt Corp., Inc. | HHR |
| Sep 30, 1985 | K852694 | PORTALASE 200 CARBON SURGICAL LASER SYSTEM Minnesota Laser Corp. | HHR |
| May 1, 1985 | K844829 | ABDOMINAL PRESSURE CONTROL VALVE L.A.S.E.R., Inc. | HHR |
| Feb 25, 1985 | K844431 | YN CO2 LASER SYSTEM 30W Cryomedics, Inc. | HHR |
| Feb 19, 1985 | K833528 | CARBON DIOXIDE LASER ML 825 Merrimack Laboratories | HHR |
| Feb 4, 1985 | K843515 | MINUTEMAN CO2 MICROSURGICAL LASER GYN American Surgical Laser, Inc. | HHR |
| Mar 5, 1982 | K820261 | MONITOR CO2 LASER SYSTEM Cooper Medical Corp. | HHR |
| Mar 17, 1981 | K810562 | CARBON DIOXIDE (C02) MICROSURGICAL LASER Metricon, Ltd. | HHR |
| Jun 30, 1980 | K801197 | CO2 LASER Advanced Biomedical Instruments | HHR |
| Mar 3, 1980 | K800227 | ML-800 CO2 Merrimack Laboratories | HHR |
| Jan 17, 1979 | K782054 | LASER, CO2 SURGICAL Cavitron Corp. | HHR |
| Nov 18, 1977 | K772023 | OB/GYN LASER, MODEL 920 Photon Sources | HHR |
| Jan 18, 1977 | K761347 | COLPOSCOPICALLY DIRECTED OB/GYN LASER Photon Sources | HHR |
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