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Profacial SLM-7654E

by SeoulinMedicare Co., Ltd.

Profacial SLM-7654E is an ultrasonic skin surface treatment unit (FDA Class I; FDA product code GFE, Brush, Dermabrasion, Powered) made by SeoulinMedicare Co., Ltd., listed in FDA GUDID since 27 May 2022 (UDI-DI 08800066170035), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800066170035 UDI-DI Date27 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Profacial
Generic name
Ultrasonic skin surface treatment unit
Model / reference
SLM-7654E
Primary DI / UDI-DI
08800066170035
FDA product code
GFE
GMDN term
Ultrasonic skin surface treatment unit
Device class
Class I
Regulation number
878.4820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ultrasonic skin surface treatment unit

Similar devices

Other devices filed under FDA product code GFE (Brush, Dermabrasion, Powered).

Other devices from SeoulinMedicare Co., Ltd.

See all devices from SeoulinMedicare Co., Ltd. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)