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FDA 510(k)

LENSTAR, MODEL LS900

K-Number: K082891 · 2009-10-20

ApplicantHaag-Streit AG
Decision Date2009-10-20
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LENSTAR, MODEL LS900 is the device name listed in this FDA 510(k) record. The listed applicant is Haag-Streit AG. It received FDA 510(k) clearance on 2009-10-20 under 510(k) number K082891. 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 LENSTAR, MODEL LS900?

LENSTAR, MODEL LS900 is a medical device that received FDA 510(k) clearance on 2009-10-20. The listed applicant is Haag-Streit AG. The 510(k) number is K082891.

When did LENSTAR, MODEL LS900 receive FDA 510(k) clearance?

LENSTAR, MODEL LS900 received FDA 510(k) clearance on 2009-10-20, under 510(k) number K082891.

Who is the listed applicant for LENSTAR, MODEL LS900?

The FDA 510(k) record lists Haag-Streit AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LENSTAR, MODEL LS900?

The FDA product code for LENSTAR, MODEL LS900 is HJO.

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Other records listing Haag-Streit AG 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.

K100202SLIT LAMP BO 900, BQ 900, BP900K982057BC 900 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

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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