Product Code: HHR FDA class 2 21 CFR 884.4550

Laser, Surgical, Gynecologic

Obstetrics/Gynecology

The Gynecologic Surgical Laser is a laser-based device used in gynecological surgery for tissue cutting, ablation, coagulation, or vaporization, applicable to procedures such as treatment of endometriosis, cervical lesions, or condyloma. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHR, regulated under 21 CFR 884.4550, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code HHR in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HHR
Device Class: FDA class 2
Regulation Number: 884.4550
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 48 510(k) clearances via K numbers.

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