Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4550](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4550) → HHR — Laser, Surgical, Gynecologic # HHR · Laser, Surgical, Gynecologic _Obstetrics/Gynecology · 21 CFR 884.4550 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR ## Overview - **Product Code:** HHR - **Device Name:** Laser, Surgical, Gynecologic - **Regulation:** [21 CFR 884.4550](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4550) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **3rd-party reviewable:** yes ## Identification A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 48) Showing 20 most recent of 48 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K881507](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K881507.md) | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES | Hgm Medical Laser Systems, Inc. | Apr 27, 1989 | SESE | | [K871875](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K871875.md) | MODEL 5050 SURGILASER FOR OB-GYN USE | Lasermatic, Inc. | Aug 22, 1988 | SESE | | [K875314](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K875314.md) | GL-35 COLPOSCOPIC LASER SYSTEM | Laser Engineering, Inc. | Aug 5, 1988 | SESE | | [K874615](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K874615.md) | LASER CANNISTER FILTER | Medical Marketing, Inc. | Jun 23, 1988 | SESE | | [K880591](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K880591.md) | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | Laser Peripherals, LLC | Jun 1, 1988 | SESE | | [K880930](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K880930.md) | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE | Copper Lasersonics, Inc. | May 31, 1988 | SESE | | [K880991](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K880991.md) | LASER OPTICAL CATHETER SYSTEM | Medline Industries, Inc. | May 25, 1988 | SESE | | [K880173](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K880173.md) | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | Cooper Lasersonics, Inc. | Mar 24, 1988 | SESE | | [K874837](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K874837.md) | KTP/532 LASER FOR OB-GYN USE | Laserscope | Mar 14, 1988 | SESE | | [K875078](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K875078.md) | HERACURE LS 500 | W.C. Heraeus GmbH | Feb 22, 1988 | SESE | | [K872709](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K872709.md) | MODEL 20-C, RL-20A/U, OB-10A/U | Directed Energy, Inc. | Feb 2, 1988 | SESE | | [K870841](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K870841.md) | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | Directed Energy, Inc. | Feb 2, 1988 | SESE | | [K864946](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K864946.md) | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE | Bio Quantum Technologies, Inc. | Jan 28, 1988 | SESE | | [K872352](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K872352.md) | FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA | Laser Media | Dec 30, 1987 | SESE | | [K872254](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K872254.md) | SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL | Surgical Laser Technologies, Inc. | Dec 14, 1987 | SESE | | [K871579](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K871579.md) | MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE | Sharplan Lasers, Inc. | Nov 16, 1987 | SESE | | [K872253](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K872253.md) | CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA | Surgical Laser Technologies, Inc. | Oct 6, 1987 | SESE | | [K871220](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K871220.md) | MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. | Cooper Lasersonics, Inc. | Jul 16, 1987 | SESE | | [K870046](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K870046.md) | DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET | Tti Medical | Mar 5, 1987 | SESE | | [K864378](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K864378.md) | CO2 LASER MICROMANIPULATOR | Transamerican Technologies Intl. | Mar 5, 1987 | SESE | ## Top Applicants - Cooper Lasersonics, Inc. — 4 clearances - Directed Energy, Inc. — 4 clearances - Endo Lase, Inc. — 3 clearances - Laser Media — 2 clearances - Laserscope — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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