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LightScalpel

FDA UDI

Class II (US FDA UDI)

by Lightscalpel Inc

Identity

Trade Name
LightScalpel FDA UDI
Generic Name
Laser adaptor FDA UDI
Device Name
Tip, 0.25mm Spot, Non-Sterile FDA UDI
Model / Reference
LS9001-03 FDA UDI
Description
Tip, 0.25mm Spot, Non-Sterile FDA UDI

Identifiers

Catalog Number
LS9001-03 Box FDA UDI
Primary DI / UDI-DI
00851842007401 FDA UDI
510(k) Number
K081612 FDA UDI
K121471 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Laser adaptor 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 0.25 Millimeter FDA UDI
Length — 20 Millimeter FDA UDI

Category: Laser adaptor

LightScalpel by Lightscalpel Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laser adaptor.

Cleared under the same submission

K081612 also covers:

K121471 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lightscalpel Inc

Sources (1)

  • FDA UDI aef43aea-1deb-4dac-858a-6c309863ba3b 38 fields · synced Jun 8, 2026