Fraxis Main Unit

FDA UDI

Class II (US FDA UDI)

by CLASSYS Inc.

Identity

Trade Name: Fraxis Main Unit FDA UDI
Generic Name: Dermatological carbon dioxide laser system FDA UDI
Model / Reference: FRX-C1 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800016903966 FDA UDI
510(k) Number: K172096 FDA UDI
FDA Product Code: GEX FDA UDI
ONG FDA UDI
GMDN Term: Dermatological carbon dioxide laser system 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dermatological carbon dioxide laser system

Fraxis Main Unit by CLASSYS Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Edge Arm — Jeisys Medical Inc. · Class II
Standard Hand-piece packing Assy, CO2RE — Candela Corporation · Class II
DEKA SMARTXIDE 50 — EL.EN. SPA · Class II

Cleared under the same submission

K172096 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: CLASSYS Inc.

Sources (1)

FDA UDI bb7ecfed-d56d-44f9-a8fa-908c3e04e283 33 fields · synced Jun 1, 2026