FDA 510(k)

TRIA LENS SET

K-Number: K843095 · 1984-10-05

Decision Date1984-10-05

Product CodeHPC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

TRIA LENS SET 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 1984-10-05 under 510(k) number K843095. The device is classified under product code HPC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIA LENS SET?

TRIA LENS SET is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Optek Medico Co., Ltd.. The 510(k) number is K843095.

When did TRIA LENS SET receive FDA 510(k) clearance?

TRIA LENS SET received FDA 510(k) clearance on 1984-10-05, under 510(k) number K843095.

Who is the listed applicant for TRIA LENS SET?

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 TRIA LENS SET?

The FDA product code for TRIA LENS SET is HPC.

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-3 K861854OPM SLIT LAMP MODEL P-1

Related Devices (Code: HPC)

K945443BOBES LENS SETBobes S.A.K951437OTI MODEL TLS-60Oti Medical, LLC K930195OPHTHALMIC TRIAL LENSESOptimark Accessories and Instruments K934859CONTACT LENSESArno Intl., Inc.K930446MARCO TRIAL SETSMarco Ophthalmic, Inc.K924786BURTON TRIAL LENS SETR.H. Burton Co.

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.