HHR · Laser, Surgical, Gynecologic
Obstetrics/Gynecology · 21 CFR 884.4550 · Class 2
Overview
| Product Code | HHR |
|---|---|
| Device Name | Laser, Surgical, Gynecologic |
| Regulation | 21 CFR 884.4550 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881507 | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES | Hgm Medical Laser Systems, Inc. | Apr 27, 1989 | SESE |
| K871875 | MODEL 5050 SURGILASER FOR OB-GYN USE | Lasermatic, Inc. | Aug 22, 1988 | SESE |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | Laser Engineering, Inc. | Aug 5, 1988 | SESE |
| K874615 | LASER CANNISTER FILTER | Medical Marketing, Inc. | Jun 23, 1988 | SESE |
| K880591 | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | Laser Peripherals, LLC | Jun 1, 1988 | SESE |
| K880930 | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE | Copper Lasersonics, Inc. | May 31, 1988 | SESE |
| K880991 | LASER OPTICAL CATHETER SYSTEM | Medline Industries, Inc. | May 25, 1988 | SESE |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | Cooper Lasersonics, Inc. | Mar 24, 1988 | SESE |
| K874837 | KTP/532 LASER FOR OB-GYN USE | Laserscope | Mar 14, 1988 | SESE |
| K875078 | HERACURE LS 500 | W.C. Heraeus GmbH | Feb 22, 1988 | SESE |
| K872709 | MODEL 20-C, RL-20A/U, OB-10A/U | Directed Energy, Inc. | Feb 2, 1988 | SESE |
| K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | Directed Energy, Inc. | Feb 2, 1988 | SESE |
| K864946 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE | Bio Quantum Technologies, Inc. | Jan 28, 1988 | SESE |
| K872352 | FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA | Laser Media | Dec 30, 1987 | SESE |
| K872254 | SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL | Surgical Laser Technologies, Inc. | Dec 14, 1987 | SESE |
| K871579 | MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE | Sharplan Lasers, Inc. | Nov 16, 1987 | SESE |
| K872253 | CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA | Surgical Laser Technologies, Inc. | Oct 6, 1987 | SESE |
| K871220 | MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. | Cooper Lasersonics, Inc. | Jul 16, 1987 | SESE |
| K870046 | DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET | Tti Medical | Mar 5, 1987 | SESE |
| K864378 | CO2 LASER MICROMANIPULATOR | Transamerican Technologies Intl. | Mar 5, 1987 | SESE |
Top Applicants
- Directed Energy, Inc. — 4 clearances
- Cooper Lasersonics, Inc. — 4 clearances
- Endo Lase, Inc. — 3 clearances
- Surgical Laser Technologies, Inc. — 2 clearances
- Photon Sources — 2 clearances
