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FDA 510(k)

ATLANTIS SLIT LAMP

K-Number: K093021 · 2010-01-28

ApplicantUs Opthalmic, LLC
Decision Date2010-01-28
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ATLANTIS SLIT LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Us Opthalmic, LLC. It received FDA 510(k) clearance on 2010-01-28 under 510(k) number K093021. 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 ATLANTIS SLIT LAMP?

ATLANTIS SLIT LAMP is a medical device that received FDA 510(k) clearance on 2010-01-28. The listed applicant is Us Opthalmic, LLC. The 510(k) number is K093021.

When did ATLANTIS SLIT LAMP receive FDA 510(k) clearance?

ATLANTIS SLIT LAMP received FDA 510(k) clearance on 2010-01-28, under 510(k) number K093021.

Who is the listed applicant for ATLANTIS SLIT LAMP?

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

What is the FDA product code for ATLANTIS SLIT LAMP?

The FDA product code for ATLANTIS SLIT LAMP is HJO.

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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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