Assy, Mask Flex Circuit, Med, Sub

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name: ASSY, MASK FLEX CIRCUIT, MED, SUB FDA UDI
Generic Name: Low-intensity laser fat liquefaction system FDA UDI
Device Name: ASSY, MASK FLEX CIRCUIT, MED, SUB FDA UDI
Model / Reference: 100-7026-816 FDA UDI
Description: ASSY, MASK FLEX CIRCUIT, MED, SUB FDA UDI

Identifiers

Primary DI / UDI-DI: 00841494107468 FDA UDI
510(k) Number: K171992 FDA UDI
FDA Product Code: PKT FDA UDI
GMDN Term: Low-intensity laser fat liquefaction system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5400 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Low-intensity laser fat liquefaction system

Assy, Mask Flex Circuit, Med, Sub by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K171992 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: Cynosure, LLC

Sources (1)

FDA UDI 35186cca-fa35-40bc-8d06-a63fd89a3a23 34 fields · synced May 30, 2026