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FDA 510(k)

BIOMICROSCOPY CONTACT LENS

K-Number: K813313 · 1982-03-01

ApplicantDesign Research Assoc., Inc.
Decision Date1982-03-01
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BIOMICROSCOPY CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Design Research Assoc., Inc.. It received FDA 510(k) clearance on 1982-03-01 under 510(k) number K813313. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMICROSCOPY CONTACT LENS?

BIOMICROSCOPY CONTACT LENS is a medical device that received FDA 510(k) clearance on 1982-03-01. The listed applicant is Design Research Assoc., Inc.. The 510(k) number is K813313.

When did BIOMICROSCOPY CONTACT LENS receive FDA 510(k) clearance?

BIOMICROSCOPY CONTACT LENS received FDA 510(k) clearance on 1982-03-01, under 510(k) number K813313.

Who is the listed applicant for BIOMICROSCOPY CONTACT LENS?

The FDA 510(k) record lists Design Research Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMICROSCOPY CONTACT LENS?

The FDA product code for BIOMICROSCOPY CONTACT LENS is HJO.

Related Clinical Trials

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Other records listing Design Research Assoc., 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.

K813315CALIPER-OPTHALMICK813314NLD IMPLANT SET

Related Devices (Code: HJO)

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.

K262637SLIT LAMP SL-D4 (Type: LED)Topcon CorporationK253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.

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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