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UltraLase Flexible Laser Waveguide

FDA UDI

Class II (US FDA UDI)

by Laser Engineering, Inc.

Identity

Trade Name
UltraLase Flexible Laser Waveguide FDA UDI
Generic Name
Urogenital surgical laser system beam guide, single-use FDA UDI
Device Name
This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient. FDA UDI
Model / Reference
HWG505 FDA UDI
Description
This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient. FDA UDI

Identifiers

Catalog Number
HWG505 FDA UDI
Primary DI / UDI-DI
00866988000216 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Urogenital surgical laser system beam guide, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Urogenital surgical laser system beam guide, single-use

UltraLase Flexible Laser Waveguide by Laser Engineering, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urogenital surgical laser system beam guide, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Laser Engineering, Inc.

Sources (1)

  • FDA UDI 61886dc5-5920-48fe-8995-5b32ccefdd58 35 fields · synced Jun 7, 2026