Refusrbished, Handpiece, 1064, Pico

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name: Refusrbished, Handpiece, 1064, Pico FDA UDI
Generic Name: Dermatological solid-state laser system FDA UDI
Device Name: Refusrbished, Handpiece, 1064, Pico FDA UDI
Model / Reference: R100-7012-079 FDA UDI
Description: Refusrbished, Handpiece, 1064, Pico FDA UDI

Identifiers

Primary DI / UDI-DI: 00841494107246 FDA UDI
510(k) Number: K160480 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dermatological solid-state 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

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: Dermatological solid-state laser system

Refusrbished, Handpiece, 1064, Pico by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatological solid-state laser system.

CLARITY II — Lutronic Corporation · Class II
AuraLux — Acclaro Corporation · Class II
GentleMax Pro — Candela Corporation · Class II
CLARITY II — Lutronic Corporation · Class II
GentleYAG — Candela Corporation · Class II
Splendor X — Bios, Inc. · Class II
EPY-50 — DDC TECHNOLOGIES, INC. · Class II
Canister HFC-134a /980g, ALUM, 15 pack — Candela Corporation · Class II

Cleared under the same submission

K160480 also covers:

PicoSure 1064 nm Handpiece — Cynosure, LLC

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 ab5b79af-20c4-4bed-b242-539fafdf77e3 34 fields · synced May 30, 2026