FDA.reportPublic FDA data

Solio

Primary DI
07290017992006
Brand
Solio
Company
HOME SKINOVATIONS LTD
Model
Solio Alfa +
Catalog number
7290017992006
Device description
An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
Published
2019-05-06
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152087000HeatLux Pro IIHome Skinovations , Ltd.2016-07-29ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017992006Direct MarkingGS10
27290017992000PackageGS11In Commercial Distribution
17290017992003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017992006072900179920067290017992006
2729001799200027290017992000
1729001799200317290017992003

GMDN Terms#

Term, Definition table
TermDefinition
Medium-wave diathermy treatment system generatorA component of a medium-wave diathermy treatment system that generates electromagnetic (EM) energy, in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz, applied transcutaneously to provide a deep heat within specific volumes of a patient's body. The energy generated by this device is typically conducted through a hand-operated electrode moved across the treatment area to treat pain, muscle spasms, and joint contractures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-367-4556contact@silkn.com

Regulatory Flags#

DUNS number
514891048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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17290015418512Silk'nGlide 150K Brazil72900154185152017-04-26
17290015418864Silk'nFlash & Go Express 72900154188672016-08-15
17290015763858Silk'nTitan72900157638512017-05-09
17290015764039Silk'nGlide Express Brazil 72900157640322017-04-26
17290015764527Silk'nBellaGlide72900157645202016-08-15
17290015764633Silk'nFaceFX 36072900157646362018-12-19
17290015764640Silk'nJewel72900157646432016-08-15
17290016627081Silk'nBellaFlash Pro72900166270842018-01-25
17290016627128Silk'nFlash & Go Pro72900166271212018-01-25
17290016627388Silk'nBellaGlide72900166273812017-07-12
17290016627852Silk'nFlash & Go LUXX72900166278552018-01-25
17290106259215PREMIER (AVOLOGI)Renelif72901062592182017-01-26
17290112450552Silk'nFlash & Go LUXX Mini-Spa72901124505552020-06-17
18712856055712Silk'nGlide87128560557152017-07-12
27290112450559Silk'nFlash & Go LUXX Mini-Spa72901124505552020-06-17
17290112452013Silk'n BellaVisage Hybrid72901124520162021-08-08

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