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FDA 510(k)

FLEXLENS, FLEXLENS TORIC

K-Number: K973192 · 1997-11-20

Decision Date1997-11-20
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FLEXLENS, FLEXLENS TORIC is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Ultravision, Inc.. It received FDA 510(k) clearance on 1997-11-20 under 510(k) number K973192. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXLENS, FLEXLENS TORIC?

FLEXLENS, FLEXLENS TORIC is a medical device that received FDA 510(k) clearance on 1997-11-20. The listed applicant is Specialty Ultravision, Inc.. The 510(k) number is K973192.

When did FLEXLENS, FLEXLENS TORIC receive FDA 510(k) clearance?

FLEXLENS, FLEXLENS TORIC received FDA 510(k) clearance on 1997-11-20, under 510(k) number K973192.

Who is the listed applicant for FLEXLENS, FLEXLENS TORIC?

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

What is the FDA product code for FLEXLENS, FLEXLENS TORIC?

The FDA product code for FLEXLENS, FLEXLENS TORIC is LPL.

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.

Other records listing Specialty Ultravision, 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.

View all 12 devices →

Related Devices (Code: LPL)

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.

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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