FDA 510(k) Applications for Medical Device Product Code "HHR"
(Laser, Surgical, Gynecologic)

FDA 510(k) Number Applicant Device Name Decision Date
K801197 ADVANCED BIOMEDICAL INSTRUMENTS CO2 LASER 06/30/1980
K843515 AMERICAN SURGICAL LASER, INC. MINUTEMAN CO2 MICROSURGICAL LASER GYN 02/04/1985
K864946 BIO QUANTUM TECHNOLOGIES, INC. ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE 01/28/1988
K851425 BRITT CORP., INC. MODEL J25-25 WATT CO2 LASER 11/12/1985
K862228 CABOT MEDICAL CORP. CABOT LASER LAPAROSCOPY ACCESSORY SET 08/20/1986
K782054 CAVITRON CORP. LASER, CO2 SURGICAL 01/17/1979
K880173 COOPER LASERSONICS, INC. MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION 03/24/1988
K863361 COOPER LASERSONICS, INC. MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA 11/24/1986
K871220 COOPER LASERSONICS, INC. MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. 07/16/1987
K862456 COOPER LASERSONICS, INC. ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION 08/12/1986
K820261 COOPER MEDICAL CORP. MONITOR CO2 LASER SYSTEM 03/05/1982
K880930 COPPER LASERSONICS, INC. MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE 05/31/1988
K844431 CRYOMEDICS, INC. YN CO2 LASER SYSTEM 30W 02/25/1985
K870841 DIRECTED ENERGY, INC. MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN 02/02/1988
K872709 DIRECTED ENERGY, INC. MODEL 20-C, RL-20A/U, OB-10A/U 02/02/1988
K861845 DIRECTED ENERGY, INC. MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE 08/11/1986
K862861 DIRECTED ENERGY, INC. SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE 10/27/1986
K853903 ENDO LASE, INC. ENDO-LASE CD40 CO2 FOR GYNECOLOGY 02/21/1986
K853876 ENDO LASE, INC. ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY 02/21/1986
K855093 ENDO LASE, INC. MEDILAS 2 ND:YAG LASER SURGERY SYSTEM 02/21/1986
K881507 HGM MEDICAL LASER SYSTEMS, INC. ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES 04/27/1989
K862227 HGM, INC. MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN 08/19/1986
K844829 L.A.S.E.R., INC. ABDOMINAL PRESSURE CONTROL VALVE 05/01/1985
K875314 LASER ENGINEERING, INC. GL-35 COLPOSCOPIC LASER SYSTEM 08/05/1988
K862444 LASER MEDIA FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA 09/25/1986
K872352 LASER MEDIA FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA 12/30/1987
K880591 LASER PERIPHERALS LLC. LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE 06/01/1988
K863520 LASER SPECTRUM, INC. CO2 LASER MICROMANIPULATOR 10/06/1986
K871875 LASERMATIC, INC. MODEL 5050 SURGILASER FOR OB-GYN USE 08/22/1988
K874837 LASERSCOPE KTP/532 LASER FOR OB-GYN USE 03/14/1988
K863221 LASERSCOPE OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN 03/02/1987
K860329 MED-TECH DEVELOMENT CORP. FYODOROV RADIAL KERATOTOMY MARKER SET 02/12/1986
K874615 MEDICAL MARKETING, INC. LASER CANNISTER FILTER 06/23/1988
K880991 MEDLINE INDUSTRIES, INC. LASER OPTICAL CATHETER SYSTEM 05/25/1988
K833528 MERRIMACK LABORATORIES CARBON DIOXIDE LASER ML 825 02/19/1985
K800227 MERRIMACK LABORATORIES ML-800 CO2 03/03/1980
K810562 METRICON, LTD. CARBON DIOXIDE (C02) MICROSURGICAL LASER 03/17/1981
K852694 MINNESOTA LASER CORP. PORTALASE 200 CARBON SURGICAL LASER SYSTEM 09/30/1985
K854470 MINNESOTA LASER CORP. PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI 02/07/1986
K761347 PHOTON SOURCES COLPOSCOPICALLY DIRECTED OB/GYN LASER 01/18/1977
K772023 PHOTON SOURCES OB/GYN LASER, MODEL 920 11/18/1977
K854361 RICHARD WOLF MEDICAL INSTRUMENTS CORP. CO2 LASER LAPAROSCOPE SYSTEM 02/04/1986
K871579 SHARPLAN LASERS, INC. MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE 11/16/1987
K872253 SURGICAL LASER TECHNOLOGIES, INC. CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA 10/06/1987
K872254 SURGICAL LASER TECHNOLOGIES, INC. SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL 12/14/1987
K864378 TRANSAMERICAN TECHNOLOGIES INTL. CO2 LASER MICROMANIPULATOR 03/05/1987
K870046 TTI MEDICAL DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET 03/05/1987
K875078 W.C. HERAEUS GMBH HERACURE LS 500 02/22/1988


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