FDA.reportPublic FDA data

ResurFX Handpiece

Primary DI
07290109143040
Brand
ResurFX Handpiece
Company
LUMENIS LTD.
Model
ResurFX Handpiece
Published
2016-09-13
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
ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130028000RESURFX 1565NM LASER MODULELumenis, Ltd.2013-09-03ONG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109143040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109143040072901091430407290109143040

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408-764-3000xxx@xxx.xxx

Regulatory Flags#

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

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
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07290109140193Slimline EZ SIS 200 FiberSlimline EZ SIS 200 Fiber2016-08-22
07290109140209Slimline EZ SIS 365 FiberSlimline EZ SIS 365 Fiber2016-08-22
07290109140216Slimline EZ SIS 550 FiberSlimline EZ SIS 550 Fiber2016-08-22
07290109140223Slimline SIS 200 FiberSlimline SIS 200 Fiber2016-08-22
07290109140230Slimline SIS 365 FiberSlimline SIS 365 Fiber2016-08-22
07290109140247Slimline SIS 550 FiberSlimline SIS 550 Fiber2016-08-22
07290109140254Slimline SIS 1000 FiberSlimline SIS 1000 Fiber2016-08-22
07290109140261Slimline™ 200 D/F/LSlimline 200 DFL FiberAC-10016352016-08-22
07290109140278Xpeeda DSL FiberXpeeda DSL FiberAC-10007292016-08-22
07290109141527AcuPulse™ Incisional Handpiece 125 mm AcuPulse™ Incisional Handpiece 125 mm AA06326002016-08-28
07290109142203SurgiTouch™ Scannerkit for AcuPulse and AcuPulse DUOKT-10001002016-08-30
07290109145662SlimLine™SlimLine™ SIS EZ 5500644-020-012022-07-25
07290109141879AcuSpotAcuSpot 712 Micromanipulator AA26300002016-09-13
07290109141916AcuSpotAcuSpot 712 L Micromanipulator AA30420002016-09-13

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