FDA.reportPublic FDA data

Silk'n

Primary DI
07290016627138
Brand
Silk'n
Company
HOME SKINOVATIONS LTD
Model
Relief International
Catalog number
7290016627138
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
Published
2017-10-18
Public version status
Update
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
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

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
07290016627138Direct MarkingGS10
27290016627132PackageGS11In Commercial Distribution
17290016627135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016627138072900166271387290016627138
2729001662713227290016627132
1729001662713517290016627135

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 Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 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
Primary DIBrandModelCatalogPublished
10074590550860RemingtonIPL350000745905508632017-07-12
10075020040319PHILIPSLumea Comfort SC19810750200403122016-08-15
10866057000311SISLOYSupreme8660570003142017-06-18
17290015418468Silk'nFlash & Go Compact72900154184612016-08-15
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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Primary DI, Brand, Company table
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