FDA Product Code
FDA Product Code HHR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4550
510(k) Clearances — 48 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K881507 | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES | Hgm Medical Laser Systems, Inc. | 1989-04-27 | Traditional | PDF ↗ |
| K871875 | MODEL 5050 SURGILASER FOR OB-GYN USE | Lasermatic, Inc. | 1988-08-22 | Traditional | PDF ↗ |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | Laser Engineering, Inc. | 1988-08-05 | Traditional | PDF ↗ |
| K874615 | LASER CANNISTER FILTER | Medical Marketing, Inc. | 1988-06-23 | Traditional | PDF ↗ |
| K880591 | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | Laser Peripherals, LLC | 1988-06-01 | Traditional | PDF ↗ |
| K880930 | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE | Copper Lasersonics, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K880991 | LASER OPTICAL CATHETER SYSTEM | Medline Industries, Inc. | 1988-05-25 | Traditional | PDF ↗ |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | Cooper Lasersonics, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K874837 | KTP/532 LASER FOR OB-GYN USE | Laserscope | 1988-03-14 | Traditional | PDF ↗ |
| K875078 | HERACURE LS 500 | W.C. Heraeus GmbH | 1988-02-22 | Traditional | PDF ↗ |
| K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | Directed Energy, Inc. | 1988-02-02 | Traditional | PDF ↗ |
| K872709 | MODEL 20-C, RL-20A/U, OB-10A/U | Directed Energy, Inc. | 1988-02-02 | Traditional | PDF ↗ |
| K864946 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE | Bio Quantum Technologies, Inc. | 1988-01-28 | Traditional | PDF ↗ |
| K872352 | FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA | Laser Media | 1987-12-30 | Traditional | PDF ↗ |
| K872254 | SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL | Surgical Laser Technologies, Inc. | 1987-12-14 | Traditional | PDF ↗ |
| K871579 | MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE | Sharplan Lasers, Inc. | 1987-11-16 | Traditional | PDF ↗ |
| K872253 | CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA | Surgical Laser Technologies, Inc. | 1987-10-06 | Traditional | PDF ↗ |
| K871220 | MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. | Cooper Lasersonics, Inc. | 1987-07-16 | Traditional | PDF ↗ |
| K864378 | CO2 LASER MICROMANIPULATOR | Transamerican Technologies Intl. | 1987-03-05 | Traditional | PDF ↗ |
| K870046 | DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET | Tti Medical | 1987-03-05 | Traditional | PDF ↗ |
| K863221 | OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN | Laserscope | 1987-03-02 | Traditional | PDF ↗ |
| K863361 | MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA | Cooper Lasersonics, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K862861 | SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE | Directed Energy, Inc. | 1986-10-27 | Traditional | PDF ↗ |
| K863520 | CO2 LASER MICROMANIPULATOR | Laser Spectrum, Inc. | 1986-10-06 | Traditional | PDF ↗ |
| K862444 | FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA | Laser Media | 1986-09-25 | Traditional | PDF ↗ |
| K862228 | CABOT LASER LAPAROSCOPY ACCESSORY SET | Cabot Medical Corp. | 1986-08-20 | Traditional | PDF ↗ |
| K862227 | MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN | Hgm, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862456 | ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION | Cooper Lasersonics, Inc. | 1986-08-12 | Traditional | PDF ↗ |
| K861845 | MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE | Directed Energy, Inc. | 1986-08-11 | Traditional | PDF ↗ |
| K853903 | ENDO-LASE CD40 CO2 FOR GYNECOLOGY | Endo Lase, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K855093 | MEDILAS 2 ND:YAG LASER SURGERY SYSTEM | Endo Lase, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K853876 | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY | Endo Lase, Inc. | 1986-02-21 | Traditional | PDF ↗ |
| K860329 | FYODOROV RADIAL KERATOTOMY MARKER SET | Med-Tech Develoment Corp. | 1986-02-12 | Traditional | PDF ↗ |
| K854470 | PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI | Minnesota Laser Corp. | 1986-02-07 | Traditional | PDF ↗ |
| K854361 | CO2 LASER LAPAROSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | 1986-02-04 | Traditional | PDF ↗ |
| K851425 | MODEL J25-25 WATT CO2 LASER | Britt Corp., Inc. | 1985-11-12 | Traditional | PDF ↗ |
| K852694 | PORTALASE 200 CARBON SURGICAL LASER SYSTEM | Minnesota Laser Corp. | 1985-09-30 | Traditional | PDF ↗ |
| K844829 | ABDOMINAL PRESSURE CONTROL VALVE | L.A.S.E.R., Inc. | 1985-05-01 | Traditional | PDF ↗ |
| K844431 | YN CO2 LASER SYSTEM 30W | Cryomedics, Inc. | 1985-02-25 | Traditional | PDF ↗ |
| K833528 | CARBON DIOXIDE LASER ML 825 | Merrimack Laboratories | 1985-02-19 | Traditional | PDF ↗ |
| K843515 | MINUTEMAN CO2 MICROSURGICAL LASER GYN | American Surgical Laser, Inc. | 1985-02-04 | Traditional | PDF ↗ |
| K820261 | MONITOR CO2 LASER SYSTEM | Cooper Medical Corp. | 1982-03-05 | Traditional | PDF ↗ |
| K810562 | CARBON DIOXIDE (C02) MICROSURGICAL LASER | Metricon, Ltd. | 1981-03-17 | Traditional | PDF ↗ |
| K801197 | CO2 LASER | Advanced Biomedical Instruments | 1980-06-30 | Traditional | PDF ↗ |
| K800227 | ML-800 CO2 | Merrimack Laboratories | 1980-03-03 | Traditional | PDF ↗ |
| K782054 | LASER, CO2 SURGICAL | Cavitron Corp. | 1979-01-17 | Traditional | PDF ↗ |
| K772023 | OB/GYN LASER, MODEL 920 | Photon Sources | 1977-11-18 | Traditional | PDF ↗ |
| K761347 | COLPOSCOPICALLY DIRECTED OB/GYN LASER | Photon Sources | 1977-01-18 | Traditional | PDF ↗ |
Product code HHR · Class II · Obstetrics/Gynecology. Data: openFDA.