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)

LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM

K-Number: K124043 · 2013-09-26

ApplicantLightmed Corp.
Decision Date2013-09-26
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lightmed Corp.. It received FDA 510(k) clearance on 2013-09-26 under 510(k) number K124043. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM?

LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-26. The listed applicant is Lightmed Corp.. The 510(k) number is K124043.

When did LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM receive FDA 510(k) clearance?

LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM received FDA 510(k) clearance on 2013-09-26, under 510(k) number K124043.

Who is the listed applicant for LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM?

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

What is the FDA product code for LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM?

The FDA product code for LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM is HQF.

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 Lightmed Corp. 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.

K103547LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEMK091981LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASERK091534LIGHTLAS MODEL 532K090774LIGHTLAS SELECTORK063297LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATORK021538LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR

View all 8 devices →

Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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.

↑