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FDA 510(k)

CORNEAL MODELING SYSTEM

K-Number: K862379 · 1986-08-25

ApplicantComputed Anatomy, Inc.
Decision Date1986-08-25
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CORNEAL MODELING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Computed Anatomy, Inc.. It received FDA 510(k) clearance on 1986-08-25 under 510(k) number K862379. 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 CORNEAL MODELING SYSTEM?

CORNEAL MODELING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-08-25. The listed applicant is Computed Anatomy, Inc.. The 510(k) number is K862379.

When did CORNEAL MODELING SYSTEM receive FDA 510(k) clearance?

CORNEAL MODELING SYSTEM received FDA 510(k) clearance on 1986-08-25, under 510(k) number K862379.

Who is the listed applicant for CORNEAL MODELING SYSTEM?

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

What is the FDA product code for CORNEAL MODELING SYSTEM?

The FDA product code for CORNEAL MODELING SYSTEM is HJO.

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.

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Other records listing Computed Anatomy, 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.

K944207TOPOGRAPHIC MODELING SYSTEM 2 TMS-2K902012VKS-1 VIDEO KERATOSCOPEK901363TOPOGRAPHIC MODELING SYSTEM

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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