FDA.reportPublic FDA data

Dermalux

Primary DI
50607624600118
Brand
Dermalux
Company
AESTHETIC TECHNOLOGY LTD
Model
Tri-Wave MD MKII
Catalog number
1000021
Device description
4-Pod LED phototherapy device.
Published
2025-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240222000Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.2024-06-04GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50607624600118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060762460011850607624600118

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1087.4Millimeter
Length679.7Millimeter
Weight55Kilogram
Width517.7Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
218753736
Device count
1
DM exempt
true
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
05060762460011DermaluxTri-Wave MD MKII10000212025-09-02
05060762460028DermaluxFlex MD10000532025-09-02
05060762460080DermaluxFlex MD10001612025-09-02
50607624600286DermaluxFlex MD10000532025-09-02
50607624600804DermaluxFlex MD10001612025-09-02

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