Laser, Surgical, Gynecologic

Product Code: HHR

Obstetrics/Gynecology Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 884.4550


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as HHR

3976Laser, Surgical, GynecologicGynecologic Surgical Laser.

Total Product Life Cycle (TPLC) Devices

3976Laser, Surgical, GynecologicGynecologic Surgical Laser.

FDA Consensus Standards

Laser, Surgical, Gynecologic [32410]21 CFR §884.4550 🔎

Pre-market Notifications for HHR

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHGM MEDICAL LASER SYSTEMS, INC.
K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELASER PERIPHERALS LLC.
K880173MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATIONCOOPER LASERSONICS, INC.
K875314GL-35 COLPOSCOPIC LASER SYSTEMLASER ENGINEERING, INC.
K875078HERACURE LS 500W.C. HERAEUS GMBH
K874837KTP/532 LASER FOR OB-GYN USELASERSCOPE
K874615LASER CANNISTER FILTERMEDICAL MARKETING, INC.
K872709MODEL 20-C, RL-20A/U, OB-10A/UDIRECTED ENERGY, INC.
K872352FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIALASER MEDIA
K872254SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITALSURGICAL LASER TECHNOLOGIES, INC.
K872253CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIASURGICAL LASER TECHNOLOGIES, INC.
K871875MODEL 5050 SURGILASER FOR OB-GYN USELASERMATIC, INC.
K871579MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USESHARPLAN LASERS, INC.
K871220MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.COOPER LASERSONICS, INC.
K870841MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYNDIRECTED ENERGY, INC.

Global Unique Device Identification Database

00814334021255LASER, SURGICAL, GYNECOLOGIC
B17770960Laser, Surgical, Gynecologic
B17770940Laser, Surgical, Gynecologic
B17770920Laser, Surgical, Gynecologic
B17770890Laser, Surgical, Gynecologic
B17770860Laser, Surgical, Gynecologic
B17770840Laser, Surgical, Gynecologic
B17770830Laser, Surgical, Gynecologic
B17770820Laser, Surgical, Gynecologic
B17770810Laser, Surgical, Gynecologic
B17770800Laser, Surgical, Gynecologic
B17770770Laser, Surgical, Gynecologic
B17770680Laser, Surgical, Gynecologic
B17770670Laser, Surgical, Gynecologic
B17770660Laser, Surgical, Gynecologic

Maude Adverse Events

ENDOMETRIAL ABLATION2015-09-30
ENDOMETRIAL ABLATION2015-09-21
THE LEGEND HTABOSTON SCIENTIFIC2011-05-18
NOVUS OMNILUMENIS, INC.2007-04-17
SURGICAL LASER TECHNOLOGYSURGICAL LASER TECHNOLOGIES2000-10-02
SLS LASERSPECIALTY SURGICAL INSTRUMENTATION, INC.1998-04-17
SHARPLAN MODEL 1041 CO2 LASERLASER INDUSTRIES, LTD1997-05-09
CO2 LASER, SHARPLANSHARPLAN LASER, INC.1996-07-26
SHARPLASE DUAL EFFECTSHARPLIN LASERS, INC.1995-08-09
LASERSONICS 1000 M BARE CHAMFERSURGIMEDICS1994-02-24
CO2 LASERLASERSONICS1992-12-02
ILLUMINA - 40 CO2 SURGICAL LASERHERAEUS LASERSONICS, INC.1992-07-06
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.