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Auryon Laser System 100-120 Vac

FDA UDI

Class II (US FDA UDI)

by Eximo Medical Ltd

Identity

Trade Name
Auryon Laser System 100-120 Vac FDA UDI
Generic Name
Atherectomy laser system beam guide-catheter, peripheral FDA UDI
Device Name
Auryon Laser System 100-120 Vac FDA UDI
Model / Reference
EXM-2001-1100 FDA UDI
Description
Auryon Laser System 100-120 Vac FDA UDI

Identifiers

Catalog Number
EXM-2001-1100 FDA UDI
Primary DI / UDI-DI
07290017590110 FDA UDI
510(k) Number
K181642 FDA UDI
K221077 FDA UDI
FDA Product Code
MCW FDA UDI
GMDN Term
Atherectomy laser system beam guide-catheter, peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4875 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

No

FDA UDI

Category: Atherectomy laser system beam guide-catheter, peripheral

Auryon Laser System 100-120 Vac by Eximo Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Atherectomy laser system beam guide-catheter, peripheral.

Cleared under the same submission

K181642 also covers:

K221077 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eximo Medical Ltd

Sources (1)

  • FDA UDI e324682e-3c0b-4eaf-a88d-016680281f58 37 fields · synced Jun 6, 2026