Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

XCEL 255 SLIT LAMP

K-Number: K063750 · 2006-12-20

ApplicantReichert, Inc.
Decision Date2006-12-20
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

XCEL 255 SLIT LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Reichert, Inc.. It received FDA 510(k) clearance on 2006-12-20 under 510(k) number K063750. 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 255 SLIT LAMP?

XCEL 255 SLIT LAMP is a medical device that received FDA 510(k) clearance on 2006-12-20. The listed applicant is Reichert, Inc.. The 510(k) number is K063750.

When did XCEL 255 SLIT LAMP receive FDA 510(k) clearance?

XCEL 255 SLIT LAMP received FDA 510(k) clearance on 2006-12-20, under 510(k) number K063750.

Who is the listed applicant for XCEL 255 SLIT LAMP?

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

What is the FDA product code for XCEL 255 SLIT LAMP?

The FDA product code for XCEL 255 SLIT LAMP is HJO.

Other records listing Reichert, 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.

K233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)K081756OCULAR RESPONSE ANALYZERK071839SOCT COPERNICUS, MODEL 15205K070534MODIFICATION TO: OCU-FILM TIP COVERK061330PSL PORTABLE SLIT LAMPK042831ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)

View all 8 devices →

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.

↑