FDA.reportPublic FDA data

Tixel Handpiece

Primary DI
07290117524053
Brand
Tixel Handpiece
Company
NOVOXEL LTD
Model
MSH00001
Device description
To be used with Tixel C Model MSTX0002
Published
2021-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202988000Tixel SystemNovoxel , Ltd.2021-02-25GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290117524053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117524053072901175240537290117524053

GMDN Terms#

Term, Definition table
TermDefinition
Thermo-mechanical skin surface treatment system handpieceA mains electricity (AC-powered), hand-held device intended to apply repetitive pulsed heat and mechanical force, via an attached heat-conductive handpiece tip, to the skin surface for ablative and/or non-ablative treatment of various skin conditions (e.g., pigmentation, scarring, actinic keratosis, acne, wrinkles) during skin resurfacing and rejuvenation procedures. It is an electronic device with an activation switch designed to connect to the system’s control unit; a handpiece tip may be included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600275858
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117524077Tixel i TXLI00012026-04-06
07290117524084Tixel i HP TiPH00012026-04-06
07290117524039Tixel 2TXLD00122024-05-23
07290117524046Tixel CMSTX00022021-11-14
07290117524060Tixel-Small Tip HandpieceMPH000012021-11-14
07290117524008TixelTXLD0002TXLD00022021-10-24
07290117524015Tixel Handpiece THLM0002THLM00022021-10-24
07290117524022Tixel Periorbital Handpiece TPH00001TPH000012021-10-24

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