Skip to content

Morelle Sos Treatment, Morelle Mamaplast, Morelle Abdoplast

by Pitt Enterprises (Silicone), Ltd.

510(k) K933811

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK933811 Date12 May 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
MDA
FDA applicant
Pitt Enterprises (Silicone) , Ltd.
Device Class
Class I
Regulation
21 CFR Part 878.4025
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent