Lp560

FDA UDI

Class II (US FDA UDI)

by Cutera, Inc.

Identity

Trade Name: LP560 FDA UDI
Generic Name: Dermatological laser beam guiding handpiece FDA UDI
Device Name: LP560 IPL Handpiece FDA UDI
Model / Reference: LP560 FDA UDI
Description: LP560 IPL Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI: 00816722022165 FDA UDI
510(k) Number: K050047 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dermatological laser beam guiding handpiece 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 laser beam guiding handpiece

Lp560 by Cutera, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dermatological laser beam guiding handpiece.

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GentleYAG 3MM Delivery System W/O DCD — Candela Corporation · Class II
External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima — Candela Corporation · Class II
TL 30 — Globalcare Medical Technology Co., Ltd. · Class IIa
Open — Candela Corporation · Class II
HydraFacial — Hydrafacial LLC · Class I

Cleared under the same submission

K050047 also covers:

OPS600 — CUTERA, INC.
ProWave 770 — CUTERA, INC.

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: Cutera, Inc.

Sources (1)

FDA UDI e031740f-353a-47eb-af9c-bd231c6fc159 35 fields · synced May 30, 2026