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FDA 510(k)

NON-ABLATIVE WRINKLE TREATMENT HANDPIECE

K-Number: K102368 · 2010-09-07

ApplicantEllman Int'L, Inc.
Decision Date2010-09-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NON-ABLATIVE WRINKLE TREATMENT HANDPIECE 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 2010-09-07 under 510(k) number K102368. 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 NON-ABLATIVE WRINKLE TREATMENT HANDPIECE?

NON-ABLATIVE WRINKLE TREATMENT HANDPIECE is a medical device that received FDA 510(k) clearance on 2010-09-07. The listed applicant is Ellman Int'L, Inc.. The 510(k) number is K102368.

When did NON-ABLATIVE WRINKLE TREATMENT HANDPIECE receive FDA 510(k) clearance?

NON-ABLATIVE WRINKLE TREATMENT HANDPIECE received FDA 510(k) clearance on 2010-09-07, under 510(k) number K102368.

Who is the listed applicant for NON-ABLATIVE WRINKLE TREATMENT HANDPIECE?

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 NON-ABLATIVE WRINKLE TREATMENT HANDPIECE?

The FDA product code for NON-ABLATIVE WRINKLE TREATMENT HANDPIECE is GEI.

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Other records listing Ellman Int'L, 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.

K102698PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFEK101967NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'K082834ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IECK061174SURGI-MAXK042710SURGITRON RADIOLASE II

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Official Source

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