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Dermosonic Non-Invasive Subdermal Therapy System

by Sybaritic, Inc.

510(k) K024307

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 NumberK024307 Date2 Jul 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0578-05 FDA Unclassified (pre-2012) initiated 5 Jan 2005

    Device is performing functions that are not cleared in the 510(k).

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  • Withdrawn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
IMI
Device Class
Class II
Regulation
21 CFR Part 890.5300
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent