Focal 44 Sublative iD (200 pulses), Profound Matrix

FDA UDI

Class II (US FDA UDI)

by Candela Corporation

Identity

Trade Name: Focal 44 Sublative iD (200 pulses), Profound Matrix FDA UDI
Generic Name: Multi-modality skin surface treatment system FDA UDI
Model / Reference: AS96121 FDA UDI

Identifiers

Primary DI / UDI-DI: 00817495023816 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Multi-modality skin surface treatment system 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multi-modality skin surface treatment system

Focal 44 Sublative iD (200 pulses), Profound Matrix by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Candela Corporation

Sources (1)

FDA UDI ecb4dbf3-fe12-449a-b7e4-eba1c59f2a6a 32 fields · synced Jun 8, 2026