Laser, Surgical, Gynecologic
FDA product code HHR · Class II (moderate risk) · 21 CFR 884.4550 · Obstetrics/Gynecology
48510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Cooper Lasersonics, Inc. 4
- Directed Energy, Inc. 4
- Endo Lase, Inc. 3
- Laserscope 2
- Merrimack Laboratories 2
- Surgical Laser Technologies, Inc. 2
- Laser Media 2
- Minnesota Laser Corp. 2
- Photon Sources 2
- Britt Corp., Inc. 1
- Hgm Medical Laser Systems, Inc. 1
- Hgm, Inc. 1
- Med-Tech Develoment Corp. 1
- Richard Wolf Medical Instruments Corp. 1
- L.A.S.E.R., Inc. 1
- Cryomedics, Inc. 1
- American Surgical Laser, Inc. 1
- Cooper Medical Corp. 1
- Metricon, Ltd. 1
- Advanced Biomedical Instruments 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881507 | Endocoagulator Model 20 Laser & AccessoriesHHR · Traditional | Hgm Medical Laser Systems, Inc. | 04/27/1989SE |
| K871875 | Model 5050 Surgilaser for Ob-Gyn UseHHR · Traditional | Lasermatic, Inc. | 08/22/1988SE |
| K875314 | GL-35 Colposcopic Laser SystemHHR · Traditional | Laser Engineering, Inc. | 08/05/1988SE |
| K874615 | Laser Cannister FilterHHR · Traditional | Medical Marketing, Inc. | 06/23/1988SE |
| K880591 | Laseguide 600A, 600B, 400A, 400B for Ob-Gyn UseHHR · Traditional | Laser Peripherals, LLC | 06/01/1988SE |
| K880930 | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LaseHHR · Traditional | Copper Lasersonics, Inc. | 05/31/1988SE |
| K880991 | Laser Optical Catheter SystemHHR · Traditional | Medline Industries, Inc. | 05/25/1988SE |
| K880173 | Model 4900 Nd:Yag Laser for Endometrial AblationHHR · Traditional | Cooper Lasersonics, Inc. | 03/24/1988SE |
| K874837 | KTP/532 Laser for Ob-Gyn UseHHR · Traditional | Laserscope | 03/14/1988SE |
| K875078 | Heracure LS 500HHR · Traditional | W.C. Heraeus GmbH | 02/22/1988SE |
| K872709 | Model 20-C, RL-20A/U, OB-10A/UHHR · Traditional | Directed Energy, Inc. | 02/02/1988SE |
| K870841 | Model 20-C W/BR-20A/U Attach/Model HL-3.0 OB/GYNHHR · Traditional | Directed Energy, Inc. | 02/02/1988SE |
| K864946 | Advanced Hand Held CO2 LASER/HH-550 for Doed UseHHR · Traditional | Bio Quantum Technologies, Inc. | 01/28/1988SE |
| K872352 | Fiberlase II Nd:Yag Laser for Treat of MenorrhagiaHHR · Traditional | Laser Media | 12/30/1987SE |
| K872254 | SLT Contact Nd:Yag Laser for Intra-Abdom.&GenitalHHR · Traditional | Surgical Laser Technologies, Inc. | 12/14/1987SE |
| K871579 | Model 2100 Nd:Yag Surgical Laser Gynecological UseHHR · Traditional | Sharplan Lasers, Inc. | 11/16/1987SE |
| K872253 | Contact Nd:Yag Laser for Treatment of MenorrhagiaHHR · Traditional | Surgical Laser Technologies, Inc. | 10/06/1987SE |
| K871220 | Modified CO2 Nd:Yag Laser Model 880, Ob-Gyn Appli.HHR · Traditional | Cooper Lasersonics, Inc. | 07/16/1987SE |
| K870046 | Double Puncture CO2 Laser Laparoscopy SetHHR · Traditional | Tti Medical | 03/05/1987SE |
| K864378 | CO2 Laser MicromanipulatorHHR · Traditional | Transamerican Technologies Intl. | 03/05/1987SE |
| K863221 | Omniplus Photosurgical Laser System for Ob-GynHHR · Traditional | Laserscope | 03/02/1987SE |
| K863361 | Model 8900 Nd:Yag Laser, Treatment of MenorrhagiaHHR · Traditional | Cooper Lasersonics, Inc. | 11/24/1986SE |
| K862861 | Surgical Carbon Dioxide Sys. Model 10-C Ob-Gyn UseHHR · Traditional | Directed Energy, Inc. | 10/27/1986SE |
| K863520 | CO2 Laser MicromanipulatorHHR · Traditional | Laser Spectrum, Inc. | 10/06/1986SE |
| K862444 | Fiberlase 100 Medical Laser Sys/Nd:Yag MenorrhagiaHHR · Traditional | Laser Media | 09/25/1986SE |
| K862228 | Cabot Laser Laparoscopy Accessory SetHHR · Traditional | Cabot Medical Corp. | 08/20/1986SE |
| K862227 | Model 8 & 20 Argon Laser for Pelvic Surgery in GynHHR · Traditional | Hgm, Inc. | 08/19/1986SE |
| K862456 | Nd:Yag Laser 4000/6000/8000 Endometrial AblationHHR · Traditional | Cooper Lasersonics, Inc. | 08/12/1986SE |
| K861845 | Model 8-B with LA-2B Attachment for Ob-Gyn UseHHR · Traditional | Directed Energy, Inc. | 08/11/1986SE |
| K855093 | Medilas 2 Nd:Yag Laser Surgery SystemHHR · Traditional | Endo Lase, Inc. | 02/21/1986SE |
| K853903 | Endo-Lase CD40 CO2 for GynecologyHHR · Traditional | Endo Lase, Inc. | 02/21/1986SE |
| K853876 | Endo-Lse CD-100 CO2 Laser for GynecologyHHR · Traditional | Endo Lase, Inc. | 02/21/1986SE |
| K860329 | Fyodorov Radial Keratotomy Marker SetHHR · Traditional | Med-Tech Develoment Corp. | 02/12/1986SE |
| K854470 | Portalase 300 Carbon Dioxide Surg Laser GynecologiHHR · Traditional | Minnesota Laser Corp. | 02/07/1986SE |
| K854361 | CO2 Laser Laparoscope SystemHHR · Traditional | Richard Wolf Medical Instruments Corp. | 02/04/1986SE |
| K851425 | Model J25-25 Watt CO2 LaserHHR · Traditional | Britt Corp., Inc. | 11/12/1985SE |
| K852694 | Portalase 200 Carbon Surgical Laser SystemHHR · Traditional | Minnesota Laser Corp. | 09/30/1985SN |
| K844829 | Abdominal Pressure Control ValveHHR · Traditional | L.A.S.E.R., Inc. | 05/01/1985SE |
| K844431 | Yn CO2 Laser System 30WHHR · Traditional | Cryomedics, Inc. | 02/25/1985SE |
| K833528 | Carbon Dioxide Laser ML 825HHR · Traditional | Merrimack Laboratories | 02/19/1985SE |
| K843515 | Minuteman CO2 Microsurgical Laser GynHHR · Traditional | American Surgical Laser, Inc. | 02/04/1985SE |
| K820261 | Monitor CO2 Laser SystemHHR · Traditional | Cooper Medical Corp. | 03/05/1982SE |
| K810562 | Carbon Dioxide (C02) Microsurgical LaserHHR · Traditional | Metricon, Ltd. | 03/17/1981SE |
| K801197 | CO2 LaserHHR · Traditional | Advanced Biomedical Instruments | 06/30/1980SE |
| K800227 | ML-800 CO2HHR · Traditional | Merrimack Laboratories | 03/03/1980SE |
| K782054 | Laser, CO2 SurgicalHHR · Traditional | Cavitron Corp. | 01/17/1979SE |
| K772023 | OB/GYN Laser, Model 920HHR · Traditional | Photon Sources | 11/18/1977SE |
| K761347 | Colposcopically Directed OB/GYN LaserHHR · Traditional | Photon Sources | 01/18/1977SE |