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FDA 510(k)

XCEL SLIT LAMP

K-Number: K951054 · 1995-03-22

ApplicantLeica, Inc.
Decision Date1995-03-22
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

XCEL SLIT LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Leica, Inc.. It received FDA 510(k) clearance on 1995-03-22 under 510(k) number K951054. 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 XCEL SLIT LAMP?

XCEL SLIT LAMP is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is Leica, Inc.. The 510(k) number is K951054.

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

XCEL SLIT LAMP received FDA 510(k) clearance on 1995-03-22, under 510(k) number K951054.

Who is the listed applicant for XCEL SLIT LAMP?

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

What is the FDA product code for XCEL SLIT LAMP?

The FDA product code for XCEL SLIT LAMP is HJO.

Other records listing Leica, 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.

K944022LENSCHEKK922770UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311

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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