FDA.reportPublic FDA data

Pretika

Primary DI
10813859001022
Brand
Pretika
Company
PRETIKA CORPORATION
Model
ST102
Catalog number
ST102
Device description
Pretika Rotating Facial Brush
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, therapeutic, electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813859001022PackageGS14In Commercial Distribution
20813859001029PackageGS16In Commercial Distribution
00813859001025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081385900102210813859001022
2081385900102920813859001029
00813859001025008138590010258138590010250813859001025

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.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00813859002909PretikaST290ST2902020-04-30
10813859002746PretikaHA274HA2742020-04-30
20813859002811PretikaST281ST2812020-04-30
20813859002880PretikaST288ST2882020-04-30
20813859002897PretikaST289ST2892020-04-30
10813859002906PretikaST290ST2902020-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00810140061355RENPHOJoicom CorporationISA2024-11-19
00810140061362RENPHOJoicom CorporationISA2024-11-19
00810140061379RENPHOJoicom CorporationISA2024-11-19
00810140061386RENPHOJoicom CorporationISA2024-11-19
00810140061393RENPHOJoicom CorporationISA2024-11-19
00810140061409RENPHOJoicom CorporationISA2024-11-19
00810140061416RENPHOJoicom CorporationISA2024-11-19
00810140061447RENPHOJoicom CorporationISA2024-11-19
00810140061690RENPHOJoicom CorporationISA2024-11-19
00810140061706RENPHOJoicom CorporationISA2024-11-19
00810140061768RENPHOJoicom CorporationISA2024-11-19
00810140061782RENPHOJoicom CorporationISA2024-11-19
00810140061799RENPHOJoicom CorporationISA2024-11-19
00810140061805RENPHOJoicom CorporationISA2024-11-19
00810140061812RENPHOJoicom CorporationISA2024-11-19