FDA 510(k)

LENS-PAC

K-Number: K813528 · 1982-01-12

Decision Date1982-01-12

Product CodeHPX

DecisionSubstantially Equivalent

Device Summary

LENS-PAC is the device name listed in this FDA 510(k) record. The listed applicant is The Plactory. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813528. The device is classified under product code HPX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LENS-PAC?

LENS-PAC is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is The Plactory. The 510(k) number is K813528.

When did LENS-PAC receive FDA 510(k) clearance?

LENS-PAC received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813528.

Who is the listed applicant for LENS-PAC?

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

What is the FDA product code for LENS-PAC?

The FDA product code for LENS-PAC is HPX.

Related Devices (Code: HPX)

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.

K955777PMMA CLASICRand Scientific Corp.K940106KERATOPLASTY SUTURING LENSVisionary Technologies of Miami, Inc.K913081MULTI-VIEW BIFOCALSCamp Contact Lenses K897021MARTIN-HENSLEY SEGMENT LENSBruce W. Martin O.D. and Edward Hensley K895411OPTIKEM PMMA CONTACT LENSOptikem Polymers, Inc.K874591ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERYVitreo Dynamics, 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.