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FDA 510(k)

DIMENSION I REFRACTION SYSTEM

K-Number: K801767 · 1980-09-16

ApplicantSmr
Decision Date1980-09-16
Product CodeHLM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIMENSION I REFRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smr. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801767. The device is classified under product code HLM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION I REFRACTION SYSTEM?

DIMENSION I REFRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Smr. The 510(k) number is K801767.

When did DIMENSION I REFRACTION SYSTEM receive FDA 510(k) clearance?

DIMENSION I REFRACTION SYSTEM received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801767.

Who is the listed applicant for DIMENSION I REFRACTION SYSTEM?

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

What is the FDA product code for DIMENSION I REFRACTION SYSTEM?

The FDA product code for DIMENSION I REFRACTION SYSTEM is HLM.

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 Smr 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.

K811623SMR PARAGON CHAIR TABLE

Related Devices (Code: HLM)

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.

K944022LENSCHEKLeica, Inc.K940997AL-3300Hoya Corp. USAK936199AUTOMATIC LENSOMETERCanon USA, Inc.K930441MARCO STANDARD LENSMETERS 101,201Marco Ophthalmic, Inc.K930445MARCO LM-770 DIGITAL PROJECTION LENSMETERMarco Ophthalmic, Inc.K924776BURTON LENSMETER - MODEL 2021R.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.

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