HHR — Laser, Surgical, Gynecologic Class II
FDA product code HHR covers "Laser, Surgical, Gynecologic", a Class II medical device regulated under 21 CFR 884.4550. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HHR
- Device Class
- Class II
- Regulation Number
- 884.4550
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K881507 | hgm medical laser systems | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES | April 27, 1989 |
| K871875 | lasermatic | MODEL 5050 SURGILASER FOR OB-GYN USE | August 22, 1988 |
| K875314 | laser engineering | GL-35 COLPOSCOPIC LASER SYSTEM | August 5, 1988 |
| K874615 | medical marketing | LASER CANNISTER FILTER | June 23, 1988 |
| K880591 | laser peripherals | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | June 1, 1988 |
| K880930 | copper lasersonics | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE | May 31, 1988 |
| K880991 | medline industries | LASER OPTICAL CATHETER SYSTEM | May 25, 1988 |
| K880173 | cooper lasersonics | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | March 24, 1988 |
| K874837 | laserscope | KTP/532 LASER FOR OB-GYN USE | March 14, 1988 |
| K875078 | w.c. heraeus | HERACURE LS 500 | February 22, 1988 |
| K870841 | directed energy | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | February 2, 1988 |
| K872709 | directed energy | MODEL 20-C, RL-20A/U, OB-10A/U | February 2, 1988 |
| K864946 | bio quantum technologies | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE | January 28, 1988 |
| K872352 | laser media | FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA | December 30, 1987 |
| K872254 | surgical laser technologies | SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL | December 14, 1987 |
| K871579 | sharplan lasers | MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE | November 16, 1987 |
| K872253 | surgical laser technologies | CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA | October 6, 1987 |
| K871220 | cooper lasersonics | MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. | July 16, 1987 |
| K864378 | transamerican technologies intl | CO2 LASER MICROMANIPULATOR | March 5, 1987 |
| K870046 | tti medical | DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET | March 5, 1987 |