Assy, Final Laser, Sculpsure, Sub Only

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name: ASSY, FINAL LASER, SCULPSURE, SUB ONLY FDA UDI
Generic Name: Low-intensity laser fat liquefaction system FDA UDI
Device Name: ASSY, FINAL LASER, SCULPSURE, SUB ONLY FDA UDI
Model / Reference: 100-7026-910 FDA UDI
Description: ASSY, FINAL LASER, SCULPSURE, SUB ONLY FDA UDI

Identifiers

Primary DI / UDI-DI: 00841494107956 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Low-intensity laser fat liquefaction system

Assy, Final Laser, Sculpsure, Sub Only by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Low-intensity laser fat liquefaction system.

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Cellulize — Photonica USA LLC · Class II
BODY LASER APPLICATOR BLISS — Venus Concept Inc. · Class II
Apolomed — Shanghai Apolo Medical Technology Co., Ltd · Class II

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 51a1e217-1d36-4ea0-8986-93461500b58c 34 fields · synced Jun 1, 2026