Del Sol Blue Light Therapy System

Primary DI
00850043007364
Brand
Del Sol Blue Light Therapy System
Company
EDGE SYSTEMS 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
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
364134791
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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Primary DI, Brand, Company table
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08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
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