FDA.reportPublic FDA data

MZ Skin LightMAX Supercharged LED Mask 2.0

Primary DI
05060534510418
Brand
MZ Skin LightMAX Supercharged LED Mask 2.0
Company
I-SMART DEVELOPMENTS LIMITED
Model
TN2025
Catalog number
140-MZ
Device description
MZ Skin Mask: MZ Skin LightMAX Supercharged LED Mask 2.0
Published
2021-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213184000MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin2021-11-23OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060534510418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060534510418050605345104185060534510418

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
223616320
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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