FDA.reportPublic FDA data

STAR

Primary DI
08056590170571
Brand
STAR
Company
ELETTRONICA PAGANI SRL
Model
STAR
Device description
Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.
Published
2023-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08056590170571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056590170571080565901705718056590170571

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality physical therapy systemAn assembly of electrically-powered devices designed to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, and microcurrent electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy, plantar fasciitis); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39029904390info@elettronicapagani.it

Regulatory Flags#

DUNS number
430315948
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056590170588STAR PLUSSTAR PLUS2023-03-27
08056590170557NEVEFACENEVEFACE2023-03-26
08056590170540NEVESKINNEVESKIN2022-04-26
08056590170441CRYO T-SHOCK 4.0CRYO T-SHOCK 4.02022-04-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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