FDA.report

NeuLight®

Primary DI
02816901024032
Brand
NeuLight®
Company
Weinert Fiber Optics, Inc.
Model
WF IR600HCT 3/SM-F 2M20Z1C
Catalog number
099471
Published
2026-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEXPowered laser surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
01816901024033PackageGS15In Commercial Distribution
02816901024032PackageGS12In Commercial Distribution
00816901024034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
01816901024033018169010240331816901024033
02816901024032028169010240322816901024032
00816901024034008169010240348169010240340816901024034

GMDN Terms

TermDefinition
Urogenital surgical laser system beam guide, single-useA flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
039281260
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
02816901023318NeuLight®WFS-600-SB0956322026-03-12
01816901024156NeuLight®WF IR600T-3/SM-F 1L30Z1S0956322026-03-12
02816901023677Typenex MedicalNV06340975112025-03-24
02816901024049NeuLight®WFS-200-SB0990732024-12-22
02816901024056NeuLight®WFR-200-SB0990712024-12-22
02816901023660Typenex MedicalNV06320975092024-11-03
01816901023975NeuLight®WF IR600/630ST-3/SM-F 1030X3S0983372024-05-10
02816901023967NeuLight®WFS-550-RTSB0957562024-05-03
01816901023395NeuLight®WFS-940-SB0951962024-02-02
01816901023722NeuLight®WFS-550-SB0954502023-09-25
01816901023845NeuLight®WFS-940-RTSB0957572023-09-25
02816901023714NeuLight®WFS-600-SF0987512023-07-31
02816901023936NeuLight®WFS-200-RTSB0957782023-07-31
02816901023943NeuLight®WFR-600-SB0956332023-07-31
02816901023950NeuLight®WFS-200-SB0951932023-07-27
01816901021339TypenexLF0101X9400975952023-06-07
01816901021292TypenexLF0101X2720975922023-06-01
01816901021308TypenexLF0101X3650975932023-06-01
01816901021315TypenexLF0101X5500975942023-06-01
01816901021384TypenexLF0101X2000975912023-06-01

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