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FDA 510(k)

DIOPTRON III AUTOREFRACTOR

K-Number: K801906 · 1980-08-27

ApplicantCoherent Medical Division
Decision Date1980-08-27
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIOPTRON III AUTOREFRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Medical Division. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801906. The device is classified under product code HKO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIOPTRON III AUTOREFRACTOR?

DIOPTRON III AUTOREFRACTOR is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Coherent Medical Division. The 510(k) number is K801906.

When did DIOPTRON III AUTOREFRACTOR receive FDA 510(k) clearance?

DIOPTRON III AUTOREFRACTOR received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801906.

Who is the listed applicant for DIOPTRON III AUTOREFRACTOR?

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

What is the FDA product code for DIOPTRON III AUTOREFRACTOR?

The FDA product code for DIOPTRON III AUTOREFRACTOR is HKO.

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 Coherent Medical Division 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.

K902990COHERENT HOLMIUM:YAG SURGICAL LASERK822908COHERENT FUNDUSL RETINAL CAMERAK822415THE OCUPLOT DK801336MODEL 900K PHOTOCOAGULATORK791895ACCESSORIES FOR SYS. 400 CO2 SURG. LASER

Related Devices (Code: HKO)

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.

K031831TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEMTopcon Medical Systems, Inc.K000327WAVESCAN WAVEFRONT SYSTEM MODEL HS 1Visx, IncorporatedK951179DIGITAL RETINOSCOPIC PHOTOMETERKudi Kalu, Inc.K945959VIDEO VISION ANALYZER (VIVA), VRB 100Tomey Corporation USAK942242AUTO REF-KERATOMETER, RK-3Cannon U.S.A., Inc.K940516AUTO REFF-30Canon, Inc.

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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