FDA product code HHR: Laser, Surgical, Gynecologic
HHR is the FDA product code for laser, surgical, gynecologic. It is a Class II device, regulated under 21 CFR 884.4550 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 48 510(k) submissions under HHR, from 34 different applicants. The average 510(k) review took 137 days (median 97).
Classification
| Field | Value |
|---|---|
| Device name | Laser, Surgical, Gynecologic |
| Device class | Class II |
| Regulation | 21 CFR 884.4550 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HHR clearance
Top HHR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cooper Lasersonics, Inc. | 4 | 1988-03-24 |
| Directed Energy, Inc. | 4 | 1988-02-02 |
| Endo Lase, Inc. | 3 | 1986-02-21 |
| Laserscope | 2 | 1988-03-14 |
| Laser Media | 2 | 1987-12-30 |
29 more applicants have HHR clearances. See the full list in Caduvo.
Most recent HHR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881507 | Hgm Medical Laser Systems, Inc. | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES | 1989-04-27 | 381 |
| K871875 | Lasermatic, Inc. | MODEL 5050 SURGILASER FOR OB-GYN USE | 1988-08-22 | 466 |
| K875314 | Laser Engineering, Inc. | GL-35 COLPOSCOPIC LASER SYSTEM | 1988-08-05 | 220 |
| K874615 | Medical Marketing, Inc. | LASER CANNISTER FILTER | 1988-06-23 | 227 |
| K880591 | Laser Peripherals, LLC | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | 1988-06-01 | 111 |
Recalls for HHR devices
openFDA lists no recalls for product code HHR.
Frequently asked questions
What is FDA product code HHR?
HHR is the FDA product code for laser, surgical, gynecologic. It is a Class II device, regulated under 21 CFR 884.4550 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHR?
Class II, regulation 21 CFR 884.4550. Typical premarket route: 510(k).
How long does a 510(k) take for product code HHR?
Across 48 cleared submissions the average was 137 days from receipt to decision (median 97).
Which companies have the most HHR clearances?
Cooper Lasersonics, Inc. (4); Directed Energy, Inc. (4); Endo Lase, Inc. (3); Laserscope (2); Laser Media (2).
Next steps
- Run an FDA pathway report with predicate devices for product code HHR
- Run a recall and safety report across every HHR manufacturer
- Watch product code HHR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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