LightSheer

Primary DI
07290109144658
Brand
LightSheer
Company
LUMENIS LTD.
Model
QUATTRO
Device description
LightSheer Quattro is a compact and portable diode laser system supporting both High-Speed Vacuum Assisted and ChillTip technologies, with six types handpieces: HS, ET and XC emitting either 805nm or 1060nm wavelengths.
Published
2019-04-02
Public version status
Update
Distribution status
Not 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
K170179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170179000LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.2017-09-18GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109144658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109144658072901091446587290109144658

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth23.6Inch
Height16.55Inch
Width20.1Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97249599000info@lumenis.com

Regulatory Flags#

DUNS number
600166524
Device count
1
Serial number
true
Manufacturing date on label
true

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