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FDA 510(k)

DOCUMENTING LASER SLIT LAMP, DP 2010

K-Number: K012873 · 2001-11-19

ApplicantBausch & Lomb, Inc.
Decision Date2001-11-19
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DOCUMENTING LASER SLIT LAMP, DP 2010 is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2001-11-19 under 510(k) number K012873. 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 DOCUMENTING LASER SLIT LAMP, DP 2010?

DOCUMENTING LASER SLIT LAMP, DP 2010 is a medical device that received FDA 510(k) clearance on 2001-11-19. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K012873.

When did DOCUMENTING LASER SLIT LAMP, DP 2010 receive FDA 510(k) clearance?

DOCUMENTING LASER SLIT LAMP, DP 2010 received FDA 510(k) clearance on 2001-11-19, under 510(k) number K012873.

Who is the listed applicant for DOCUMENTING LASER SLIT LAMP, DP 2010?

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

What is the FDA product code for DOCUMENTING LASER SLIT LAMP, DP 2010?

The FDA product code for DOCUMENTING LASER SLIT LAMP, DP 2010 is HJO.

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Other records listing Bausch & Lomb, Inc. as applicant

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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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