Identity
- Trade Name
- Pretika FDA UDI
- Generic Name
- Ultrasonic skin surface treatment unit FDA UDI
- Device Name
- SonicDermabrasion 2.0 FDA UDI
- Model / Reference
- ST289 FDA UDI
- Description
- SonicDermabrasion 2.0 FDA UDI
Identifiers
- Catalog Number
- ST289 FDA UDI
- Primary DI / UDI-DI
- 00813859002893 FDA UDI
- FDA Product Code
- ISA FDA UDIGET FDA UDI
- GMDN Term
- Ultrasonic skin surface treatment unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 FDA UDI878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasonic skin surface treatment unit
Pretika by Pretika Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic skin surface treatment unit.
- Profacial — SeoulinMedicare Co., Ltd. · Class I
- Pretika — Pretika Corporation · Class I
- Pretika — Pretika Corporation · Class I
- Pretika — Pretika Corporation · Class I
- Pretika — Pretika Corporation · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pretika Corporation
Sources (1)
- FDA UDI 25c4a077-af82-4bf0-ad6e-dd4d0035b07a 35 fields · synced May 30, 2026