Novilase

FDA UDI

Class II (US FDA UDI)

by Novian Health Inc.

Identity

Trade Name: Novilase FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: Novilase Laser Therapy System for focal destruction breast tumors. For distribution in the UK. FDA UDI
Model / Reference: LTS 2.1 (UK) FDA UDI
Description: Novilase Laser Therapy System for focal destruction breast tumors. For distribution in the UK. FDA UDI

Identifiers

Catalog Number: 100001-03 FDA UDI
Primary DI / UDI-DI: 00860008944887 FDA UDI
510(k) Number: K160392 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: General/multiple surgical diode 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: General/multiple surgical diode laser system

Novilase by Novian Health Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical diode laser system.

QuadroStar PRO — Asclepion Laser Technologies GmbH · Class II
Doctor Diode Laser — LAMBDA SPA · Class II
TxCell for IQ577, H/S 900BM/BQ & CSO9900 — Iridex Corporation · Class II
Dornier MedTech — Dornier MedTech GmbH · Class II
Assy Final HS SLA IQ532 Standard Mount — Iridex Corporation · Class II
Visualase — MEDTRONIC NAVIGATION, INC. · Class I
GIGAA — Wuhan Gigaa Optronics Technology Co., Ltd. · Class II
Epic S-Series Diode Laser System — Biolase, Inc. · Class II

Cleared under the same submission

K160392 also covers:

Novilase — Novian Health Inc.
Novilase — Novian Health 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Novian Health Inc.

Sources (1)

FDA UDI d82e62c3-fce0-44b4-88ab-d770863e22e1 36 fields · synced Jun 9, 2026