Radiolase 3

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name: RADIOLASE 3 FDA UDI
Generic Name: Electrosurgical system FDA UDI
Device Name: RADIOLASE 3 GENERATOR 110V FDA UDI
Model / Reference: RL3-D50/110 FDA UDI
Description: RADIOLASE 3 GENERATOR 110V FDA UDI

Identifiers

Catalog Number: RL3-D50/110 FDA UDI
Primary DI / UDI-DI: 00841494104351 FDA UDI
510(k) Number: K042710 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical system

Radiolase 3 by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K042710 also covers:

ACUSECT — Cynosure, LLC
AcuSect — 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 680f1c31-ef46-47de-aa9e-d2d409fc8462 35 fields · synced Jun 8, 2026