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IRLightSurgN

FDA UDI

Class II (US FDA UDI)

by Smartsurgn Inc.

Identity

Trade Name
IRLightSurgN FDA UDI
Generic Name
Endoscopic video image processing/light source system FDA UDI
Device Name
LED & Laser Light Source FDA UDI
Model / Reference
10020 FDA UDI
Description
LED & Laser Light Source FDA UDI

Identifiers

Primary DI / UDI-DI
G465100200 FDA UDI
510(k) Number
K213943 FDA UDI
FDA Product Code
OWN FDA UDI
GMDN Term
Endoscopic video image processing/light source system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic video image processing/light source system

IRLightSurgN by Smartsurgn Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic video image processing/light source system.

Cleared under the same submission

K213943 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smartsurgn Inc.

Sources (1)

  • FDA UDI c590286e-33a6-4495-84b0-f7e99c877140 34 fields · synced Jun 1, 2026