FDA 510(k)

NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'

K-Number: K101967 · 2010-08-12

Decision Date2010-08-12

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' 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 2010-08-12 under 510(k) number K101967. 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 TREATENT HANDPIECE MODLE PELLEVE'?

NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' is a medical device that received FDA 510(k) clearance on 2010-08-12. The listed applicant is Ellman Int'L, Inc.. The 510(k) number is K101967.

When did NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' receive FDA 510(k) clearance?

NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' received FDA 510(k) clearance on 2010-08-12, under 510(k) number K101967.

Who is the listed applicant for NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'?

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 TREATENT HANDPIECE MODLE PELLEVE'?

The FDA product code for NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' is GEI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K102698PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE K102368NON-ABLATIVE WRINKLE TREATMENT HANDPIECE K082834ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC K061174SURGI-MAX K042710SURGITRON RADIOLASE II

Related Devices (Code: GEI)

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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.