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FDA 510(k)

SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE

K-Number: K875104 · 1988-02-02

ApplicantLaserguide
Decision Date1988-02-02
Product CodeLLO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE is the device name listed in this FDA 510(k) record. The listed applicant is Laserguide. It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K875104. The device is classified under product code LLO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE?

SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Laserguide. The 510(k) number is K875104.

When did SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE receive FDA 510(k) clearance?

SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE received FDA 510(k) clearance on 1988-02-02, under 510(k) number K875104.

Who is the listed applicant for SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE?

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

What is the FDA product code for SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE?

The FDA product code for SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE is LLO.

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 Laserguide 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.

K880071SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USEK873892SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USEK873571LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBEK873664LIGHT-SPOT FIBEROPTIC LASER HANDPIECE

Related Devices (Code: LLO)

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.

K884815SLT CLMD CONTACT LASERSurgical Laser Technologies, Inc.K881499SURGILASE YAG 100 FOR GYNECOLOGY USESurgilase, Inc.K880592LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USELaser Peripherals, LLCK880170MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSCooper Lasersonics, Inc.K874254ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONSMinnesota Laser Corp.K871876MODEL 5050 SURGILASER FOR PULMONARY USELasermatic, 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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