Slimlipo Tip, 100mm Length, EO

Primary DI
00841494100490
Brand
Slimlipo Tip, 100mm Length, EO
Company
Cynosure, LLC
Model
0320-0029
Device description
Slimlipo Tip, 100mm Length, EO
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K083165000
K100270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083165000PALOMAR ASPIRE LASER PLATFORMPalomar Medical Products, Inc.2009-02-13GEX
K100270000ARTISAN AESTHETIC SYSTEMPalomar Medical Technologies, Inc.2010-03-29GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841494100497PackageGS15In Commercial Distribution
00841494100490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084149410049710841494100497
00841494100490008414941004908414941004900841494100490

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical frequency-doubled solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
780318028
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

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00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
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