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Finebeam

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K202288Ref SNJ-UM-007Model Finebeam

by Snj Co., Ltd

Identity

Trade Name
Finebeam EUDAMEDFDA UDI
Generic Name
Dermatological frequency-doubled solid-state laser system FDA UDI
Device Name
Nd:YAG Surgical Laser EUDAMED
Model / Reference
Finebeam EUDAMEDFDA UDI
SNJ-UM-007 EUDAMED

Identifiers

Primary DI / UDI-DI
08800086000015 EUDAMEDFDA UDI
Basic UDI-DI
B-08800086000015 EUDAMED
510(k) Number
K202288 FDA 510(k)FDA UDI
FDA Product Code
GEX FDA 510(k)FDA UDI
EMDN Code
Z12011017 NEODYMIUM SURGICAL 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
Spain 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

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

The Finebeam Dual Q-Switched and Long-Pulse Nd:YAG Laser System is a dual-mode laser device designed for dermatological and plastic surgery applications. It combines Q-switched and long-pulsed laser technologies to address a range of skin and vascular conditions, including pigmentation disorders, tattoos, and vascular lesions.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings by trained professionals. It is classified under the Product Code GEX and has received FDA 510(k) clearance and MDD authorization, ensuring compliance with regulatory standards. The system requires proper maintenance and storage as outlined in manufacturer guidelines to ensure safety and performance.

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: Finebeam Dual | Q-Switched and Long pulse nd yag - SNJ, FINEBEAM Trademark | Bizapedia, Finebeam by SNJ Co., Ltd. | FDA 510 (k) Summary

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Snj Co., Ltd
FDA Applicant
SNJ Co., Ltd.

Sources (3)

  • FDA 510(k) K202288 24 fields · synced Sep 18, 2026
  • FDA UDI 53885003-9ff0-4396-ae90-15318dc262c5 33 fields · synced May 30, 2026
  • EUDAMED 7f3030c7-3077-4eca-8ebd-fecacab776dd 61 fields · synced Jul 14, 2026