Joule

FDA UDI

Class II (US FDA UDI)

by Sciton, Inc.

Identity

Trade Name: JOULE FDA UDI
Generic Name: Multi-modality skin surface treatment system FDA UDI
Device Name: Multi-platform laser/light device for medical use. FDA UDI
Model / Reference: JOULE FDA UDI
Description: Multi-platform laser/light device for medical use. FDA UDI

Identifiers

Catalog Number: 1500-XXX-XX FDA UDI
Primary DI / UDI-DI: 00863249000305 FDA UDI
FDA Product Code: GEX FDA UDI
ONG FDA UDI
ORK FDA UDI
ONF FDA UDI
GMDN Term: Multi-modality skin surface treatment 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality skin surface treatment system

Joule by Sciton, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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2940 handpiece — Cynosure, LLC · Class II

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: Sciton, Inc.

Sources (1)

FDA UDI 06572df5-f5fb-40f9-87e4-fd462c0657ef 36 fields · synced May 31, 2026