Enlighten Iii

EUDAMEDFDA 510(k)FDA UDI

Class IIb (EU MDR)

Ref ENLIGHTENIII510(k) K170936

by Cutera, Inc.

Identity

Trade Name: enlighten III EUDAMED
enlighten FDA UDI
Generic Name: Dermatological frequency-doubled solid-state laser system FDA UDI
Device Name: enlighten III EUDAMED
enlighten Family EUDAMED
enlighten III Laser System FDA UDI
Model / Reference: ENLIGHTENIII EUDAMED
enlighten III FDA UDI
Description: enlighten III Laser System FDA UDI

Identifiers

Primary DI / UDI-DI: 00816722021649 EUDAMEDFDA UDI
Basic UDI-DI: B-00816722021649 EUDAMED
00816722021600DC EUDAMED
510(k) Number: K170936 FDA 510(k)
FDA Product Code: GEX FDA 510(k)FDA UDI
EMDN Code: Z12011019 MULTI–PLATFORM LASER EUDAMED
GMDN Term: Dermatological frequency-doubled solid-state laser system FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 878.4810 FDA 510(k)
Regulation Number: 878.4810 FDA 510(k)FDA UDI
Market of Registration: France EUDAMED
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

The Enlighten Iii is a Class IIb laser system with a 670 nm wavelength, used for the treatment of benign pigmented lesions and tattoo removal. It has multiple wavelengths, including 532nm, 1064nm, and 670nm, and features dual pulse duration, allowing for both pico and nano second speed. The device is designed to selectively shatter unwanted pigment and induce dermal disruption and remodeling for skin revitalization.

The Enlighten Iii is supplied as a single-use device and is not reusable. It is not implantable and does not administer medicine. The device has been authorized with FDA 510K, MDD, and MDR approvals. It is available with a unique device identifier (UDI) and is manufactured by Cutera, Inc.

Frequently asked questions

What is the Enlighten III used for?

The Enlighten III is used for the treatment of benign pigmented lesions and tattoo removal, utilizing its multiple wavelengths to selectively shatter unwanted pigment.

Is the Enlighten III a reusable device?

No, the Enlighten III is supplied as a single-use device and is not reusable, ensuring safety and preventing potential contamination.

What wavelengths does the Enlighten III feature?

The Enlighten III features multiple wavelengths, including 532nm, 1064nm, and 670nm, allowing for dual pulse duration and both pico and nano second speed.

Is the Enlighten III implantable or does it administer medicine?

No, the Enlighten III is not implantable and does not administer medicine, it is designed for external use only.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: enlighten - CUTERA, Enlighten III Review: Cutera's $140K Pico Laser, Enlighten® III Laser System by Cutera, Inc. | ModernLaserIQ™, PDF Cutera enlighten III brochure 1 - leaderhealthcaregroup.com

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-00816722021649	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K170936	Class IIb	Active
EUDAMED	European Union	CE/MDD	B-00816722021649	Class IIb	Active

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Manufacturer

Manufacturer: Cutera, Inc.
EUDAMED SRN: US-MF-000010456
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (4)

EUDAMED ac11f40c-99ee-4d4c-85a1-97de11139d03 61 fields · synced Sep 27, 2026
FDA 510(k) K170936 24 fields · synced May 18, 2026
FDA UDI 2c7d848d-b979-4ecd-92d2-a871a42adf81 34 fields · synced May 30, 2026
EUDAMED 07bd109f-2683-4d75-afd5-f289d00eb5e1 61 fields · synced Jul 31, 2026