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FDA 510(k)

OTI MODEL TLS-60

K-Number: K951437 · 1995-04-11

ApplicantOti Medical, LLC
Decision Date1995-04-11
Product CodeHPC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OTI MODEL TLS-60 is the device name listed in this FDA 510(k) record. The listed applicant is Oti Medical, LLC. It received FDA 510(k) clearance on 1995-04-11 under 510(k) number K951437. 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 OTI MODEL TLS-60?

OTI MODEL TLS-60 is a medical device that received FDA 510(k) clearance on 1995-04-11. The listed applicant is Oti Medical, LLC. The 510(k) number is K951437.

When did OTI MODEL TLS-60 receive FDA 510(k) clearance?

OTI MODEL TLS-60 received FDA 510(k) clearance on 1995-04-11, under 510(k) number K951437.

Who is the listed applicant for OTI MODEL TLS-60?

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

What is the FDA product code for OTI MODEL TLS-60?

The FDA product code for OTI MODEL TLS-60 is HPC.

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.

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Other records listing Oti Medical, LLC 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.

K951184OTI MODEL 78-60

Related Devices (Code: HPC)

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.

K945443BOBES LENS SETBobes S.A.K930195OPHTHALMIC TRIAL LENSESOptimark Accessories and InstrumentsK934859CONTACT LENSESArno Intl., Inc.K930446MARCO TRIAL SETSMarco Ophthalmic, Inc.K924786BURTON TRIAL LENS SETR.H. Burton Co.K920571TRIAL 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.

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