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LithoWise

FDA UDI

Class II (US FDA UDI)

by Fiberoptic Fabrications, Inc.

Identity

Trade Name
LithoWise FDA UDI
Generic Name
General/multiple surgical laser system beam guide, single-use FDA UDI
Device Name
400 micrometer laser fiber FDA UDI
Model / Reference
LW-1002 FDA UDI
Description
400 micrometer laser fiber FDA UDI

Identifiers

Primary DI / UDI-DI
00861062000359 FDA UDI
510(k) Number
K120810 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple 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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: General/multiple surgical laser system beam guide, single-use

LithoWise by Fiberoptic Fabrications, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical laser system beam guide, single-use.

Cleared under the same submission

K120810 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fiberoptic Fabrications, Inc.

Sources (1)

  • FDA UDI a6d3016d-e08f-4eb6-9fed-0e86e9a20faf 34 fields · synced May 30, 2026