FDA.reportPublic FDA data

Novilase

Primary DI
00860008944870
Brand
Novilase
Company
Novian Health Inc.
Model
LTS 2.1 (EU/Switzerland)
Catalog number
100001-02
Device description
Novilase Laser Therapy System for focal destruction breast tumors. For distribution in Europe and Switzerland.
Published
2023-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160392000Novilase Laser Therapy System, Model LTS-2Novian Health, Inc.2016-02-26GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008944870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008944870008600089448708600089448700860008944870

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3122667200info@novianhealth.com

Regulatory Flags#

DUNS number
011736427
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008944887NovilaseLTS 2.1 (UK)100001-032023-11-15
00860008944825NovilaseLTS 2.1 (USA)100001-012023-11-12
00860011448006Novilase Laser Therapy PackSwitzerland: 150 mm100011-032023-12-13
00196852073344Novilase Laser Therapy PackSwitzerland: 150 mm100011-032023-11-15
00860008944818Novilase Laser Therapy PackUSA/EU/UK: 150 mm100011-012023-11-15
00860008944894Novilase Laser Therapy PackSwitzerland: 110 mm100011-042023-11-15
00860008944801Novilase Laser Therapy PackUSA/EU/UK: 110 mm100011-022023-11-12

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Primary DI, Brand, Company table
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