elysion-pro

Primary DI
08437020651141
Brand
elysion-pro
Company
HIGH TECHNOLOGY PRODUCTS SL
Model
ELYSION diode laser hair removal system
Catalog number
522040
Device description
ELYSION diode laser hair removal system with 755nm and 810nm and applicators include: • Hair Removal withStatic and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in thenumber of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Treatment ofPseudofolliculitis barbae (PFB)
Published
2020-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K193367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193367000elysion-proHigh Technology Products S.L.U2020-03-12GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437020651141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437020651141084370206511418437020651141

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to remove unwanted body hair (e.g., armpit, leg/arm, back, chest, bikini line, and face). It is intended to be used by a trained professional to emit pulsed light of a wavelength around 808 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat. Also known as a laser epilator, it typically includes a control unit with dedicated software and user interface, delivery handpiece, and foot-switch.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+34934588566info@cocoonmedical.com

Regulatory Flags#

DUNS number
462514006
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437020651011primelase excellencePRIMELASE diode laser hair removal system5210282020-04-09

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