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FDA 510(k)

NOVAKONE SPHERICAL AND TORIC LENSES

K-Number: K102557 · 2011-04-26

Decision Date2011-04-26
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NOVAKONE SPHERICAL AND TORIC LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Alden Optical Labs., Inc.. It received FDA 510(k) clearance on 2011-04-26 under 510(k) number K102557. 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 NOVAKONE SPHERICAL AND TORIC LENSES?

NOVAKONE SPHERICAL AND TORIC LENSES is a medical device that received FDA 510(k) clearance on 2011-04-26. The listed applicant is Alden Optical Labs., Inc.. The 510(k) number is K102557.

When did NOVAKONE SPHERICAL AND TORIC LENSES receive FDA 510(k) clearance?

NOVAKONE SPHERICAL AND TORIC LENSES received FDA 510(k) clearance on 2011-04-26, under 510(k) number K102557.

Who is the listed applicant for NOVAKONE SPHERICAL AND TORIC LENSES?

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

What is the FDA product code for NOVAKONE SPHERICAL AND TORIC LENSES?

The FDA product code for NOVAKONE SPHERICAL AND TORIC LENSES 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 Alden Optical Labs., 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 10 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

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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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