Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COLPOSCOPICALLY DIRECTED OB/GYN LASER

K-Number: K761347 · 1977-01-18

ApplicantPhoton Sources
Decision Date1977-01-18
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COLPOSCOPICALLY DIRECTED OB/GYN LASER is the device name listed in this FDA 510(k) record. The listed applicant is Photon Sources. It received FDA 510(k) clearance on 1977-01-18 under 510(k) number K761347. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLPOSCOPICALLY DIRECTED OB/GYN LASER?

COLPOSCOPICALLY DIRECTED OB/GYN LASER is a medical device that received FDA 510(k) clearance on 1977-01-18. The listed applicant is Photon Sources. The 510(k) number is K761347.

When did COLPOSCOPICALLY DIRECTED OB/GYN LASER receive FDA 510(k) clearance?

COLPOSCOPICALLY DIRECTED OB/GYN LASER received FDA 510(k) clearance on 1977-01-18, under 510(k) number K761347.

Who is the listed applicant for COLPOSCOPICALLY DIRECTED OB/GYN LASER?

The FDA 510(k) record lists Photon Sources as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLPOSCOPICALLY DIRECTED OB/GYN LASER?

The FDA product code for COLPOSCOPICALLY DIRECTED OB/GYN LASER is HHR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Photon Sources as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K772023OB/GYN LASER, MODEL 920

Related Devices (Code: HHR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑