650nm Revlite SI Dye Handpiece, Red

Primary DI
00841494100346
Brand
650nm Revlite SI Dye Handpiece, Red
Company
Cynosure, LLC
Model
100-7017-063
Device description
650nm Revlite SI Dye Handpiece, Red
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K103118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103118000REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTORHoya Photonics, Inc.2010-11-19GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494100346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494100346008414941003468414941003460841494100346

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological 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 intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm). 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

Regulatory Flags#

DUNS number
780318028
Device count
1
Serial number
true

Other Devices From This Company#

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00841494107468ASSY, MASK FLEX CIRCUIT, MED, SUB100-7026-8162017-09-26
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00841494107994RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLYR100-7026-9102018-01-18
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00841494100100Accolade100-7008-0102016-09-24
00841494100551Spacer tip, handpiece130-7012-3242016-09-24
00841494100568Spacer tip for 532 Handpiece130-7012-4902016-09-24
00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
00841494103675Elite+ / Elite MPX Treatment Tip100-7018-1002016-09-24
00841494106775SculpSure, Laser Assembly, Brazil100-7026-0202017-07-24

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