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Tixel Periorbital Handpiece

FDA UDIEUDAMED

Class II (US FDA UDI)

by Novoxel Ltd

Identity

Trade Name
Tixel Periorbital Handpiece FDA UDI
Generic Name
Thermo-mechanical skin surface treatment system handpiece FDA UDI
Device Name
Handpiece used with Tixel System TXLD0002 FDA UDI
Model / Reference
TPH00001 FDA UDI
Description
Handpiece used with Tixel System TXLD0002 FDA UDI

Identifiers

Catalog Number
TPH00001 FDA UDI
Primary DI / UDI-DI
07290117524022 FDA UDI
510(k) Number
K202988 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Thermo-mechanical skin surface treatment system handpiece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Thermo-mechanical skin surface treatment system handpiece

Tixel Periorbital Handpiece by Novoxel Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Thermo-mechanical skin surface treatment system handpiece.

Cleared under the same submission

K202988 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novoxel Ltd

Sources (2)

  • FDA UDI 8205db56-9001-43d7-bf32-5b97059821be 35 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026