FDA 510(k)

ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES

K-Number: K091327 · 2010-06-25

Decision Date2010-06-25

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT 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 2010-06-25 under 510(k) number K091327. 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 ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES?

ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Alden Optical Labs., Inc.. The 510(k) number is K091327.

When did ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES receive FDA 510(k) clearance?

ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES received FDA 510(k) clearance on 2010-06-25, under 510(k) number K091327.

Who is the listed applicant for ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT 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 ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES?

The FDA product code for ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES is LPL.

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Other records listing Alden Optical Labs., Inc. as applicant

K133079IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)K102557NOVAKONE SPHERICAL AND TORIC LENSES K052703ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL K042242ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES K983278OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)K983053ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)

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Related Devices (Code: LPL)

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.