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)

OPHTHALMIC TRIAL LENSES

K-Number: K930195 · 1994-01-06

ApplicantOptimark Accessories and Instruments
Decision Date1994-01-06
Product CodeHPC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC TRIAL LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Optimark Accessories and Instruments. It received FDA 510(k) clearance on 1994-01-06 under 510(k) number K930195. The device is classified under product code HPC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC TRIAL LENSES?

OPHTHALMIC TRIAL LENSES is a medical device that received FDA 510(k) clearance on 1994-01-06. The listed applicant is Optimark Accessories and Instruments. The 510(k) number is K930195.

When did OPHTHALMIC TRIAL LENSES receive FDA 510(k) clearance?

OPHTHALMIC TRIAL LENSES received FDA 510(k) clearance on 1994-01-06, under 510(k) number K930195.

Who is the listed applicant for OPHTHALMIC TRIAL LENSES?

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

What is the FDA product code for OPHTHALMIC TRIAL LENSES?

The FDA product code for OPHTHALMIC TRIAL LENSES is HPC.

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

Related Devices (Code: HPC)

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.

K945443BOBES LENS SETBobes S.A.K951437OTI MODEL TLS-60Oti Medical, LLCK934859CONTACT LENSESArno Intl., Inc.K930446MARCO TRIAL SETSMarco Ophthalmic, Inc.K924786BURTON TRIAL LENS SETR.H. Burton Co.K920571TRIAL LENS SETR.H. Burton Co.

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.

↑