FDA 510(k)

PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE

K-Number: K102698 · 2011-01-05

Decision Date2011-01-05

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE is the device name listed in this FDA 510(k) record. The listed applicant is Ellman Int'L, Inc.. It received FDA 510(k) clearance on 2011-01-05 under 510(k) number K102698. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE?

PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE is a medical device that received FDA 510(k) clearance on 2011-01-05. The listed applicant is Ellman Int'L, Inc.. The 510(k) number is K102698.

When did PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE receive FDA 510(k) clearance?

PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE received FDA 510(k) clearance on 2011-01-05, under 510(k) number K102698.

Who is the listed applicant for PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE?

The FDA 510(k) record lists Ellman Int'L, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE?

The FDA product code for PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE is GEI.

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Other records listing Ellman Int'L, Inc. as applicant

K102368NON-ABLATIVE WRINKLE TREATMENT HANDPIECE K101967NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'K082834ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC K061174SURGI-MAX K042710SURGITRON RADIOLASE II

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Official Source

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