FDA.reportPublic FDA data

Del Sol Blue Light Therapy System

Primary DI
00850043007371
Brand
Del Sol Blue Light Therapy System
Company
Hydrafacial LLC
Model
Cordless (EU)
Catalog number
70392-01
Device description
Del Sol Blue Cordless LED Light for EU/CE only
Published
2017-07-03
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
00850043007364PackageGS11In Commercial Distribution
00850043007371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043007364008500430073648500430073640850043007364
00850043007371008500430073718500430073710850043007371

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.

Contacts#

Phone, Email table
PhoneEmail
800-603-4996regulatory@hydrafacial.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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