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FDA 510(k)

GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72

K-Number: K080776 · 2008-09-09

ApplicantUs Ophthalmic, LLC
Decision Date2008-09-09
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 is the device name listed in this FDA 510(k) record. The listed applicant is Us Ophthalmic, LLC. It received FDA 510(k) clearance on 2008-09-09 under 510(k) number K080776. 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 GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72?

GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 is a medical device that received FDA 510(k) clearance on 2008-09-09. The listed applicant is Us Ophthalmic, LLC. The 510(k) number is K080776.

When did GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 receive FDA 510(k) clearance?

GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 received FDA 510(k) clearance on 2008-09-09, under 510(k) number K080776.

Who is the listed applicant for GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72?

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

What is the FDA product code for GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72?

The FDA product code for GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 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 Us Ophthalmic, LLC 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.

K063416LUXVISION SLIT LAMP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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