Laser, Surgical, Gynecologic

FDA product code HHR · 48 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.4550
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-01-18 – 1989-04-27

HHR 1989-04-27

ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES

Applicant Hgm Medical Laser Systems, Inc.

K number K881507

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HHR 1988-08-22

MODEL 5050 SURGILASER FOR OB-GYN USE

Applicant Lasermatic, Inc.

K number K871875

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HHR 1988-08-05

GL-35 COLPOSCOPIC LASER SYSTEM

Applicant Laser Engineering, Inc.

K number K875314

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HHR 1988-06-23

LASER CANNISTER FILTER

Applicant Medical Marketing, Inc.

K number K874615

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HHR 1988-06-01

LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE

Applicant Laser Peripherals, LLC

K number K880591

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HHR 1988-05-31

MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE

Applicant Copper Lasersonics, Inc.

K number K880930

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HHR 1988-05-25

LASER OPTICAL CATHETER SYSTEM

Applicant Medline Industries, Inc.

K number K880991

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HHR 1988-03-24

MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION

Applicant Cooper Lasersonics, Inc.

K number K880173

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HHR 1988-03-14

KTP/532 LASER FOR OB-GYN USE

Applicant Laserscope

K number K874837

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HHR 1988-02-22

HERACURE LS 500

Applicant W.C. Heraeus GmbH

K number K875078

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HHR 1988-02-02

MODEL 20-C, RL-20A/U, OB-10A/U

Applicant Directed Energy, Inc.

K number K872709

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HHR 1988-02-02

MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN

Applicant Directed Energy, Inc.

K number K870841

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HHR 1988-01-28

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE

Applicant Bio Quantum Technologies, Inc.

K number K864946

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HHR 1987-12-30

FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA

Applicant Laser Media

K number K872352

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HHR 1987-12-14

SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL

Applicant Surgical Laser Technologies, Inc.

K number K872254

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HHR 1987-11-16

MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE

Applicant Sharplan Lasers, Inc.

K number K871579

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HHR 1987-10-06

CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA

Applicant Surgical Laser Technologies, Inc.

K number K872253

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HHR 1987-07-16

MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.

Applicant Cooper Lasersonics, Inc.

K number K871220

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HHR 1987-03-05

DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET

Applicant Tti Medical

K number K870046

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HHR 1987-03-05

CO2 LASER MICROMANIPULATOR

Applicant Transamerican Technologies Intl.

K number K864378

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HHR 1987-03-02

OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN

Applicant Laserscope

K number K863221

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HHR 1986-11-24

MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA

Applicant Cooper Lasersonics, Inc.

K number K863361

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HHR 1986-10-27

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE

Applicant Directed Energy, Inc.

K number K862861

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HHR 1986-10-06

CO2 LASER MICROMANIPULATOR

Applicant Laser Spectrum, Inc.

K number K863520

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HHR 1986-09-25

FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA

Applicant Laser Media

K number K862444

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HHR 1986-08-20

CABOT LASER LAPAROSCOPY ACCESSORY SET

Applicant Cabot Medical Corp.

K number K862228

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HHR 1986-08-19

MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN

Applicant Hgm, Inc.

K number K862227

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HHR 1986-08-12

ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION

Applicant Cooper Lasersonics, Inc.

K number K862456

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HHR 1986-08-11

MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE

Applicant Directed Energy, Inc.

K number K861845

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HHR 1986-02-21

MEDILAS 2 ND:YAG LASER SURGERY SYSTEM

Applicant Endo Lase, Inc.

K number K855093

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HHR 1986-02-21

ENDO-LASE CD40 CO2 FOR GYNECOLOGY

Applicant Endo Lase, Inc.

K number K853903

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HHR 1986-02-21

ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY

Applicant Endo Lase, Inc.

K number K853876

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HHR 1986-02-12

FYODOROV RADIAL KERATOTOMY MARKER SET

Applicant Med-Tech Develoment Corp.

K number K860329

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HHR 1986-02-07

PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI

Applicant Minnesota Laser Corp.

K number K854470

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HHR 1986-02-04

CO2 LASER LAPAROSCOPE SYSTEM

Applicant Richard Wolf Medical Instruments Corp.

K number K854361

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HHR 1985-11-12

MODEL J25-25 WATT CO2 LASER

Applicant Britt Corp., Inc.

K number K851425

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HHR 1985-09-30

PORTALASE 200 CARBON SURGICAL LASER SYSTEM

Applicant Minnesota Laser Corp.

K number K852694

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HHR 1985-05-01

ABDOMINAL PRESSURE CONTROL VALVE

Applicant L.A.S.E.R., Inc.

K number K844829

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HHR 1985-02-25

YN CO2 LASER SYSTEM 30W

Applicant Cryomedics, Inc.

K number K844431

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HHR 1985-02-19

CARBON DIOXIDE LASER ML 825

Applicant Merrimack Laboratories

K number K833528

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HHR 1985-02-04

MINUTEMAN CO2 MICROSURGICAL LASER GYN

Applicant American Surgical Laser, Inc.

K number K843515

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HHR 1982-03-05

MONITOR CO2 LASER SYSTEM

Applicant Cooper Medical Corp.

K number K820261

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HHR 1981-03-17

CARBON DIOXIDE (C02) MICROSURGICAL LASER

Applicant Metricon, Ltd.

K number K810562

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HHR 1980-06-30

CO2 LASER

Applicant Advanced Biomedical Instruments

K number K801197

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HHR 1980-03-03

ML-800 CO2

Applicant Merrimack Laboratories

K number K800227

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HHR 1979-01-17

LASER, CO2 SURGICAL

Applicant Cavitron Corp.

K number K782054

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HHR 1977-11-18

OB/GYN LASER, MODEL 920

Applicant Photon Sources

K number K772023

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HHR 1977-01-18

COLPOSCOPICALLY DIRECTED OB/GYN LASER

Applicant Photon Sources

K number K761347

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