HHR · Class II · 21 CFR 884.4550

FDA Product Code HHR: Laser, Surgical, Gynecologic

Leading manufacturers include Directed Energy, Inc., Cooper Lasersonics, Inc. and Laserscope.

48
Total
48
Cleared
137d
Avg days
1977
Since

FDA 510(k) Cleared Laser, Surgical, Gynecologic Devices (Product Code HHR)

48 devices
1–24 of 48
Cleared May 25, 1988
LASER OPTICAL CATHETER SYSTEM
K880991
Medline Industries, Inc.
Obstetrics & Gynecology · 78d
Cleared Mar 24, 1988
MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
K880173
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 69d
Cleared Mar 14, 1988
KTP/532 LASER FOR OB-GYN USE
K874837
Laserscope
Obstetrics & Gynecology · 111d
Cleared Feb 02, 1988
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
K870841
Directed Energy, Inc.
Obstetrics & Gynecology · 341d
Cleared Feb 02, 1988
MODEL 20-C, RL-20A/U, OB-10A/U
K872709
Directed Energy, Inc.
Obstetrics & Gynecology · 210d
Cleared Dec 14, 1987
SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL
K872254
Surgical Laser Technologies, Inc.
Obstetrics & Gynecology · 208d
Cleared Nov 16, 1987
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
K871579
Sharplan Lasers, Inc.
Obstetrics & Gynecology · 207d
Cleared Oct 06, 1987
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
K872253
Surgical Laser Technologies, Inc.
Obstetrics & Gynecology · 139d
Cleared Jul 16, 1987
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
K871220
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 118d
Cleared Mar 02, 1987
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN
K863221
Laserscope
Obstetrics & Gynecology · 193d
Cleared Nov 24, 1986
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA
K863361
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 83d
Cleared Oct 27, 1986
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
K862861
Directed Energy, Inc.
Obstetrics & Gynecology · 90d
Cleared Aug 20, 1986
CABOT LASER LAPAROSCOPY ACCESSORY SET
K862228
Cabot Medical Corp.
Obstetrics & Gynecology · 70d
Cleared Aug 12, 1986
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
K862456
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 46d
Cleared Aug 11, 1986
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
K861845
Directed Energy, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 04, 1986
CO2 LASER LAPAROSCOPE SYSTEM
K854361
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 98d
Cleared Jan 17, 1979
LASER, CO2 SURGICAL
K782054
Cavitron Corp.
Obstetrics & Gynecology · 41d

About Product Code HHR - Regulatory Context