Product code HHR— Obstetrics/Gynecology

FDA has cleared 48 devices under product code HHR between 1977 and 1989, filed by 34 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19891 clearance
• 198812 clearances
• 19878 clearances
• 198614 clearances
• 19856 clearances
• 19821 clearance
• 19811 clearance
• 19802 clearances
• 19791 clearance
• 19772 clearances

• Directed Energy, Inc.4 clearances
• Cooper Lasersonics, Inc.4 clearances
• Endo Lase, Inc.3 clearances
• Surgical Laser Technologies, Inc.2 clearances
• Photon Sources2 clearances
• Minnesota Laser Corp.2 clearances
• Merrimack Laboratories2 clearances
• Laserscope2 clearances
• Laser Media2 clearances
• W.C. Heraeus GmbH1 clearance

• K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.·1989-04-27
• K871875 — MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.·1988-08-22
• K875314 — GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.·1988-08-05
• K874615 — LASER CANNISTER FILTERMedical Marketing, Inc.·1988-06-23
• K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLC·1988-06-01
• K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, Inc.·1988-05-31
• K880991 — LASER OPTICAL CATHETER SYSTEMMedline Industries, Inc.·1988-05-25
• K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATIONCooper Lasersonics, Inc.·1988-03-24
• K874837 — KTP/532 LASER FOR OB-GYN USELaserscope·1988-03-14
• K875078 — HERACURE LS 500W.C. Heraeus GmbH·1988-02-22
• K870841 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYNDirected Energy, Inc.·1988-02-02
• K872709 — MODEL 20-C, RL-20A/U, OB-10A/UDirected Energy, Inc.·1988-02-02
• K864946 — ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USEBio Quantum Technologies, Inc.·1988-01-28
• K872352 — FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIALaser Media·1987-12-30
• K872254 — SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITALSurgical Laser Technologies, Inc.·1987-12-14
• K871579 — MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USESharplan Lasers, Inc.·1987-11-16
• K872253 — CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIASurgical Laser Technologies, Inc.·1987-10-06
• K871220 — MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.Cooper Lasersonics, Inc.·1987-07-16
• K864378 — CO2 LASER MICROMANIPULATORTransamerican Technologies Intl.·1987-03-05
• K870046 — DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SETTti Medical·1987-03-05
• K863221 — OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYNLaserscope·1987-03-02
• K863361 — MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIACooper Lasersonics, Inc.·1986-11-24
• K862861 — SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USEDirected Energy, Inc.·1986-10-27
• K863520 — CO2 LASER MICROMANIPULATORLaser Spectrum, Inc.·1986-10-06
• K862444 — FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIALaser Media·1986-09-25
• K862228 — CABOT LASER LAPAROSCOPY ACCESSORY SETCabot Medical Corp.·1986-08-20
• K862227 — MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYNHgm, Inc.·1986-08-19
• K862456 — ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATIONCooper Lasersonics, Inc.·1986-08-12
• K861845 — MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USEDirected Energy, Inc.·1986-08-11
• K853876 — ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGYEndo Lase, Inc.·1986-02-21
• K853903 — ENDO-LASE CD40 CO2 FOR GYNECOLOGYEndo Lase, Inc.·1986-02-21
• K855093 — MEDILAS 2 ND:YAG LASER SURGERY SYSTEMEndo Lase, Inc.·1986-02-21
• K860329 — FYODOROV RADIAL KERATOTOMY MARKER SETMed-Tech Develoment Corp.·1986-02-12
• K854470 — PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGIMinnesota Laser Corp.·1986-02-07
• K854361 — CO2 LASER LAPAROSCOPE SYSTEMRichard Wolf Medical Instruments Corp.·1986-02-04
• K851425 — MODEL J25-25 WATT CO2 LASERBritt Corp., Inc.·1985-11-12
• K852694 — PORTALASE 200 CARBON SURGICAL LASER SYSTEMMinnesota Laser Corp.·1985-09-30
• K844829 — ABDOMINAL PRESSURE CONTROL VALVEL.A.S.E.R., Inc.·1985-05-01
• K844431 — YN CO2 LASER SYSTEM 30WCryomedics, Inc.·1985-02-25
• K833528 — CARBON DIOXIDE LASER ML 825Merrimack Laboratories·1985-02-19
• K843515 — MINUTEMAN CO2 MICROSURGICAL LASER GYNAmerican Surgical Laser, Inc.·1985-02-04
• K820261 — MONITOR CO2 LASER SYSTEMCooper Medical Corp.·1982-03-05
• K810562 — CARBON DIOXIDE (C02) MICROSURGICAL LASERMetricon, Ltd.·1981-03-17
• K801197 — CO2 LASERAdvanced Biomedical Instruments·1980-06-30
• K800227 — ML-800 CO2Merrimack Laboratories·1980-03-03
• K782054 — LASER, CO2 SURGICALCavitron Corp.·1979-01-17
• K772023 — OB/GYN LASER, MODEL 920Photon Sources·1977-11-18
• K761347 — COLPOSCOPICALLY DIRECTED OB/GYN LASERPhoton Sources·1977-01-18