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)

ELLEX SLIT LAMP, MODEL 30XL

K-Number: K063352 · 2007-03-13

ApplicantTakagi Seiko Co., Ltd.
Decision Date2007-03-13
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ELLEX SLIT LAMP, MODEL 30XL is the device name listed in this FDA 510(k) record. The listed applicant is Takagi Seiko Co., Ltd.. It received FDA 510(k) clearance on 2007-03-13 under 510(k) number K063352. 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 ELLEX SLIT LAMP, MODEL 30XL?

ELLEX SLIT LAMP, MODEL 30XL is a medical device that received FDA 510(k) clearance on 2007-03-13. The listed applicant is Takagi Seiko Co., Ltd.. The 510(k) number is K063352.

When did ELLEX SLIT LAMP, MODEL 30XL receive FDA 510(k) clearance?

ELLEX SLIT LAMP, MODEL 30XL received FDA 510(k) clearance on 2007-03-13, under 510(k) number K063352.

Who is the listed applicant for ELLEX SLIT LAMP, MODEL 30XL?

The FDA 510(k) record lists Takagi Seiko Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELLEX SLIT LAMP, MODEL 30XL?

The FDA product code for ELLEX SLIT LAMP, MODEL 30XL is HJO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Takagi Seiko Co., Ltd. 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.

K182491Applanation tonometer AT-2K172728Applanation tonometer AT-1K162636Marco Ultra M3, Marco Ultra M4K152535Z5 Slit lamp microscope, Z2 Slit lamp microscope

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.

↑