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FDA 510(k)

OPM SLIT LAMP MODEL P-1

K-Number: K861854 · 1986-07-11

ApplicantOptek Medico Co., Ltd.
Decision Date1986-07-11
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPM SLIT LAMP MODEL P-1 is the device name listed in this FDA 510(k) record. The listed applicant is Optek Medico Co., Ltd.. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K861854. 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 OPM SLIT LAMP MODEL P-1?

OPM SLIT LAMP MODEL P-1 is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Optek Medico Co., Ltd.. The 510(k) number is K861854.

When did OPM SLIT LAMP MODEL P-1 receive FDA 510(k) clearance?

OPM SLIT LAMP MODEL P-1 received FDA 510(k) clearance on 1986-07-11, under 510(k) number K861854.

Who is the listed applicant for OPM SLIT LAMP MODEL P-1?

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

What is the FDA product code for OPM SLIT LAMP MODEL P-1?

The FDA product code for OPM SLIT LAMP MODEL P-1 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 Optek Medico 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.

K863048OPM SLIT LAMP MODEL P-1 & MODEL P-3K843095TRIA LENS SET

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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