# Pretika ST148

> Listed: FDA GUDID listing, no authorization on record. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/pretika-st148>
- Manufacturer: [Pretika Corporation](https://devicerts.com/manufacturers/pretika-corporation) (FDA registration: United States)
- Device class: Class I (US FDA)
- FDA product code: ISA, GFE
- GMDN: Ultrasonic skin surface treatment unit (64428)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00813859001483 · listed 2021-02-19 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: Pretika [FDA GUDID (AccessGUDID)]
- Generic name: Ultrasonic skin surface treatment unit [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: ST148 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00813859001483 [FDA GUDID (AccessGUDID)]
- FDA product code: ISA [FDA GUDID (AccessGUDID)]; GFE [FDA GUDID (AccessGUDID)]
- GMDN term: Ultrasonic skin surface treatment unit (64428) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 890.5660 [FDA GUDID (AccessGUDID)]; 878.4820 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Over-the-counter: Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Pretika ST148, Pretika Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/pretika-st148 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/pretika-st148.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/pretika-st148
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.