FDA.reportPublic FDA data

Del Sol Blue Light Therapy System

Primary DI
00850043007012
Brand
Del Sol Blue Light Therapy System
Company
Hydrafacial LLC
Model
Cordless (US)
Catalog number
70392
Device description
Blue Cordless LED - US
Published
2017-08-16
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061470000DEL SOL BLUE LIGHT THERAPY SYSTEMEdge Systems Corporation2006-07-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043007012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043007012008500430070128500430070120850043007012

GMDN Terms#

Term, Definition table
TermDefinition
Skin photodynamic therapy/phototherapy lampA portable, mains electricity (AC-powered) lamp intended to emit low-level narrow-band (LLNB) red light (e.g., 600-650nm) and blue light (e.g., 415-440nm) either separately or simultaneously for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as actinic keratosis and non-melanoma skin cancer, and for phototherapy applications (through modification of skin metabolism) to treat skin complaints such as acne, rosacea and sun spots. It uses light-emitting diodes (LEDs) to produce a heatless light source which may be used for treatment at multiple anatomical sites. It is intended to be used by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-603-4996contact@edgeforlife.com

Regulatory Flags#

DUNS number
364134791
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810007533643Hydrafacial™ Syndeo™ BLACK 240V KOREA240V Black, Non Medical2026-03-27
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMSKINSTYLUS STERILOCK MICROSYSTEM2026-03-27
00810007534268Hydrafacial™ SkinStylus™ Nano QuickStart Kit (Non Medical)Hydrafacial™ SkinStylus™ Nano QuickStart Kit (Non 2026-03-27
00810007534794Hydrafacial™ Elite System, 240V INTERNATIONAL240V Black, Non Medical70290-03-01-ITL2026-03-13
00810007532394Hydrafacial Syndeo 120V, Black7000078-BLK2024-07-11
00810007531311Hydrafacial MD Elite240V70290-03-012024-07-18
00810007531540Hydrafacial MD Elite120V70143-03-012024-07-18
00810007531595Hydrafacial MD Allegro120V704152024-07-18
00810007532400Hydrafacial Syndeo 240V Black7000079-BLK2024-07-18
00810007532479Hydrafacial Syndeo 120V, White7000078-WHT2024-07-18
00810007532486Hydrafacial Syndeo 240V White7000079-WHT2024-07-18
00810007532493Hydrafacial Syndeo 240V White No-Perk7000079-WHT-NPK2024-07-18
00810007532509Hydrafacial Syndeo 120V, White No Perk7000078-WHT-NPK2024-07-18
00810007532516Hydrafacial Syndeo240V Black No Perk7000079-BLK-NPK2024-07-18
00810007532523Hydrafacial Syndeo 120V, Black No Perk7000078-BLK-NPK2024-07-18
00810007533605Hydrafacial Syndeo 240V Black, Non Medical 7000079-BLK-NMD2024-07-18
00810007533711Hydrafacial Syndeo 120V Black, Non Medical7000078-BLK-NMD2024-07-18
00810007533728Hydrafacial Allegro SPA240V704142024-07-18
00810007533735Dior Syndeo240V Assembly7000079-BLK-DIOR2024-07-18
00810007533742Dior Syndeo120V Assembly7000078-BLK-DIOR2024-07-18

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Primary DI, Brand, Company table
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