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)

LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE

K-Number: K914484 · 1992-01-06

ApplicantHgm Medical Laser Systems, Inc.
Decision Date1992-01-06
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Hgm Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 1992-01-06 under 510(k) number K914484. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE?

LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1992-01-06. The listed applicant is Hgm Medical Laser Systems, Inc.. The 510(k) number is K914484.

When did LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE receive FDA 510(k) clearance?

LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE received FDA 510(k) clearance on 1992-01-06, under 510(k) number K914484.

Who is the listed applicant for LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE?

The FDA 510(k) record lists Hgm Medical Laser Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE?

The FDA product code for LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE is HLI.

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 Hgm Medical Laser Systems, Inc. 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.

K921300MODEL PC ARGON ION LASERK913569COMPAC A, ELITE A, ELITE A PLUS, SURGICA AK912628AIR ARGON ION LASERS VARIOUS MODELSK910272HGM COMBINATION ND:YAG & SOLID STATE GREENK912438MODELS 5,8,20,20S ARGON ION LASERSK910602HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY

View all 18 devices →

Related Devices (Code: HLI)

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.

K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KGK121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.

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.

↑