UltraScan CPG

Primary DI
07290109144245
Brand
UltraScan CPG
Company
LUMENIS LTD.
Model
UltraScan CPG
Device description
Additional DM UDI: 07290109144252
Published
2021-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K203544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203544000UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.2020-12-24GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109144245Direct MarkingGS10
07290109145051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109144245072901091442457290109144245
07290109145051072901091450517290109145051

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state/carbon dioxide laser systemA mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one solid-state [e.g., neodymium-doped yttrium-aluminium-garnet (Nd:YAG)] mediated and the other carbon dixoide (CO2) mediated, intended for bloodless incisions during general surgery and/or multiple specialized surgical applications (non-dedicated). It is intended to provide both the cutting capabilities of gas mediated lasing, and the haemostatic abilities of solid-state mediated lasing. It includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include frequency doubling technology.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600166524
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true

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