FDA.reportPublic FDA data

Pretika

Primary DI
00813859002909
Brand
Pretika
Company
PRETIKA CORPORATION
Model
ST290
Catalog number
ST290
Device description
Pretika® Advanced Acne Cleansing Brush
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFEBrush, dermabrasion, powered
ISAMassager, therapeutic, electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813859002906PackageGS14In Commercial Distribution
20813859002903PackageGS16In Commercial Distribution
00813859002909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081385900290610813859002906
2081385900290320813859002903
00813859002909008138590029098138590029090813859002909

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic skin surface treatment unitAn electrically-powered, hand-held device intended to apply ultrasonic vibration to the skin surface, typically the face, for treatment of acne and/or for deep cleansing. It is used in timed sessions where the vibrational energy is intended to open and unclog skin pores. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(949)488-8818thomasnichols@pretika.com

Regulatory Flags#

DUNS number
848304379
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813859001483PretikaST148ST1482021-02-19
10813859001480PretikaST148ST1482021-02-19
00813859002619PretikaST261ST2612019-07-01
00813859001025PretikaST102ST1022020-04-30
00813859002749PretikaHA274HA2742020-04-30
00813859002817PretikaST281ST2812020-04-30
00813859002886PretikaST288ST2882020-04-30
00813859002893PretikaST289ST2892020-04-30
10813859001022PretikaST102ST1022020-04-30
10813859002746PretikaHA274HA2742020-04-30
20813859002811PretikaST281ST2812020-04-30
20813859002880PretikaST288ST2882020-04-30
20813859002897PretikaST289ST2892020-04-30
10813859002906PretikaST290ST2902020-04-30

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Primary DI, Brand, Company table
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07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00810007533643Hydrafacial™ Syndeo™ BLACK 240V KOREAHydrafacial LLCGFE2026-03-27
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMHydrafacial LLCGFE2026-03-27
00810007534268Hydrafacial™ SkinStylus™ Nano QuickStart Kit (Non Medical)Hydrafacial LLCGFE2026-03-27
08053782383733T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-03-25
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
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00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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00810140061355RENPHOJoicom CorporationISA2024-11-19
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G589CPMNT030CosmopenCosmoFranceGFE2024-04-02