Product code HHR
- Device name
- Laser, Surgical, Gynecologic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4550
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881507 | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES | Hgm Medical Laser Systems, Inc. | 1989-04-27 |
| K871875 | MODEL 5050 SURGILASER FOR OB-GYN USE | Lasermatic, Inc. | 1988-08-22 |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | Laser Engineering, Inc. | 1988-08-05 |
| K874615 | LASER CANNISTER FILTER | Medical Marketing, Inc. | 1988-06-23 |
| K880591 | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | Laser Peripherals, LLC | 1988-06-01 |
| K880930 | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE | Copper Lasersonics, Inc. | 1988-05-31 |
| K880991 | LASER OPTICAL CATHETER SYSTEM | Medline Industries, Inc. | 1988-05-25 |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | Cooper Lasersonics, Inc. | 1988-03-24 |
| K874837 | KTP/532 LASER FOR OB-GYN USE | Laserscope | 1988-03-14 |
| K875078 | HERACURE LS 500 | W.C. Heraeus GmbH | 1988-02-22 |
| K872709 | MODEL 20-C, RL-20A/U, OB-10A/U | Directed Energy, Inc. | 1988-02-02 |
| K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | Directed Energy, Inc. | 1988-02-02 |
| K864946 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE | Bio Quantum Technologies, Inc. | 1988-01-28 |
| K872352 | FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA | Laser Media | 1987-12-30 |
| K872254 | SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL | Surgical Laser Technologies, Inc. | 1987-12-14 |
| K871579 | MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE | Sharplan Lasers, Inc. | 1987-11-16 |
| K872253 | CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA | Surgical Laser Technologies, Inc. | 1987-10-06 |
| K871220 | MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. | Cooper Lasersonics, Inc. | 1987-07-16 |
| K870046 | DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET | Tti Medical | 1987-03-05 |
| K864378 | CO2 LASER MICROMANIPULATOR | Transamerican Technologies Intl. | 1987-03-05 |
| K863221 | OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN | Laserscope | 1987-03-02 |
| K863361 | MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA | Cooper Lasersonics, Inc. | 1986-11-24 |
| K862861 | SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE | Directed Energy, Inc. | 1986-10-27 |
| K863520 | CO2 LASER MICROMANIPULATOR | Laser Spectrum, Inc. | 1986-10-06 |
| K862444 | FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA | Laser Media | 1986-09-25 |
| K862228 | CABOT LASER LAPAROSCOPY ACCESSORY SET | Cabot Medical Corp. | 1986-08-20 |
| K862227 | MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN | Hgm, Inc. | 1986-08-19 |
| K862456 | ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION | Cooper Lasersonics, Inc. | 1986-08-12 |
| K861845 | MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE | Directed Energy, Inc. | 1986-08-11 |
| K853876 | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY | Endo Lase, Inc. | 1986-02-21 |
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| B1771104R0 | Accu-Beam | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL | 2025-02-25 |
| B177062537602T0 | Accu-Beam | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL | 2024-08-06 |
| B17770560 | Accu-Beam | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL | 2024-02-20 |
| B1777021650 | Accu-Beam | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL | 2024-01-09 |
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| B177A55014900TTI0 | Accu-Beam | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL | 2024-01-04 |
| B1771109R0 | Accu-Beam | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL | 2022-08-23 |
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| B17711230 | Accu-Beam | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL | 2019-12-17 |
| B17704342043D0 | Accu-Beam | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL | 2017-10-26 |
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| B17711020 | Accu-Beam | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL | 2016-07-07 |