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SureLase

FDA UDI

Class II (US FDA UDI)

by Clinicon Corp.

Identity

Trade Name
SureLase FDA UDI
Generic Name
General/multiple surgical diode/carbon dioxide laser system FDA UDI
Device Name
Clinicon "SureLase" 30 Watt Laser System, 3-Year Warranty FDA UDI
Model / Reference
4060 FDA UDI
Description
Clinicon "SureLase" 30 Watt Laser System, 3-Year Warranty FDA UDI

Identifiers

Primary DI / UDI-DI
00850013050215 FDA UDI
510(k) Number
K121580 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical diode/carbon dioxide laser system 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

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General/multiple surgical diode/carbon dioxide laser system

SureLase by Clinicon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical diode/carbon dioxide laser system.

Cleared under the same submission

K121580 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clinicon Corp.

Sources (1)

  • FDA UDI e4088f4b-2027-4c00-bc4e-ba68fe6f6f7f 34 fields · synced May 30, 2026