FDA.reportPublic FDA data

UltraLase Flexible Laser Waveguide

Primary DI
10866988000213
Brand
UltraLase Flexible Laser Waveguide
Company
LASER ENGINEERING
Model
HWG505
Catalog number
HWG505
Device description
This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.
Published
2021-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10866988000213PackageGS13In Commercial Distribution
00866988000216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086698800021310866988000213
00866988000216008669880002168669880002160866988000216

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
5085202552r.rudko@laserengineering.com

Regulatory Flags#

DUNS number
028541358
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866988000292Laser EngineeringHWG305-OTOHWG305-OTO2024-08-20
00866988000285Laser EngineeringHWG305HWG3052024-08-20
10866988000299Laser EngineeringHWG305-OTOHWG305-OTO2024-08-20
00860011139706Laser EngineeringOTO Handpiece10597462024-04-11
00866988000216UltraLase Flexible Laser WaveguideHWG505HWG5052021-11-08
00866988000230ImperiumCO2-500CO2-5002018-12-31
00866988000261UltraLase Flexible Laser WaveguideHWG300-OTOHWG300-OTO2020-03-23
00866988000209UltraLase Flexible Laser WaveguideHWG500-2.0-3.0HWG500-2.0-3.02016-09-20
00866988000223UltraLase Flexible Laser WaveguideHWG300-2.0-3.0HWG300-2.0-3.02016-09-20
00866988000247ImperiumCO2-300CO2-3002018-12-31
10866988000268UltraLase Flexible Laser WaveguideHWG300-OTOHWG300-OTO2020-03-23
10866988000237ImperiumCO2-500CO2-5002018-12-31

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Primary DI, Brand, Company table
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08800291820484HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
06973511890177SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-06-10
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