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Frax Pro

FDA UDI

Class II (US FDA UDI)

by Candela Corporation

Identity

Trade Name
Frax Pro FDA UDI
Generic Name
Multi-modality skin surface treatment system generator FDA UDI
Device Name
Frax Pro FDA UDI
Model / Reference
9SYS7852-001-CNDL FDA UDI
Description
Frax Pro FDA UDI

Identifiers

Primary DI / UDI-DI
00817495023465 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Multi-modality skin surface treatment system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality skin surface treatment system generator

Frax Pro by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality skin surface treatment system generator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Candela Corporation

Sources (1)

  • FDA UDI 2b3d440f-9ac6-4c9f-8a07-b206c3389018 33 fields · synced Jun 8, 2026