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Ellman International Non-Ablative Technique for Surgitron Iec

by Ellman Intl., Inc.

510(k) K082834

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082834 Date7 May 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1624-2012 FDA Not yet classified initiated 4 May 2012

    Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
FDA applicant
Ellman Int'L, Inc.
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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