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Pretika ST289

by Pretika Corporation

Pretika ST289 is an ultrasonic skin surface treatment unit (FDA Class I) made by Pretika Corporation, listed in FDA GUDID since 30 Apr 2020 (UDI-DI 00813859002893), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813859002893 UDI-DI Date30 Apr 2020ListedStatusListed 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  • Withdrawn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
Pretika
Generic name
Ultrasonic skin surface treatment unit
Model / Ref / Catalog
ST289
Primary DI / UDI-DI
00813859002893
FDA product code
ISA, GET
GMDN term
Ultrasonic skin surface treatment unit
Device class
Class I
Regulation number
890.5660, 878.4820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ultrasonic skin surface treatment unit

Similar devices

Also classified as Ultrasonic skin surface treatment unit.

Similar devices

Other devices filed under FDA product code ISA (Massager, therapeutic, electric).

Other devices from Pretika Corporation

See all devices from Pretika Corporation →

Properties

  • Over-the-counter
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)