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FDA 510(k)

OB/GYN LASER, MODEL 920

K-Number: K772023 · 1977-11-18

ApplicantPhoton Sources
Decision Date1977-11-18
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OB/GYN LASER, MODEL 920 is the device name listed in this FDA 510(k) record. The listed applicant is Photon Sources. It received FDA 510(k) clearance on 1977-11-18 under 510(k) number K772023. 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 OB/GYN LASER, MODEL 920?

OB/GYN LASER, MODEL 920 is a medical device that received FDA 510(k) clearance on 1977-11-18. The listed applicant is Photon Sources. The 510(k) number is K772023.

When did OB/GYN LASER, MODEL 920 receive FDA 510(k) clearance?

OB/GYN LASER, MODEL 920 received FDA 510(k) clearance on 1977-11-18, under 510(k) number K772023.

Who is the listed applicant for OB/GYN LASER, MODEL 920?

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 OB/GYN LASER, MODEL 920?

The FDA product code for OB/GYN LASER, MODEL 920 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.

K761347COLPOSCOPICALLY DIRECTED OB/GYN LASER

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

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

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