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MDElite iProX

FDA UDI

Class II (US FDA UDI)

by MDElite Laser and Aesthetic, LLC

Identity

Trade Name
MDElite iProX FDA UDI
Generic Name
Intense pulsed light skin surface treatment system FDA UDI
Device Name
MDElite iProX - Intense Pulsed Light Equipment - AC110V 50/60Hz 2500VA 34*57*118cm 62kg - FDA 510(k) K193328 FDA UDI
Model / Reference
iProX FDA UDI
Description
MDElite iProX - Intense Pulsed Light Equipment - AC110V 50/60Hz 2500VA 34*57*118cm 62kg - FDA 510(k) K193328 FDA UDI

Identifiers

Primary DI / UDI-DI
00860007876806 FDA UDI
FDA Product Code
ONF FDA UDI
GEX FDA UDI
GMDN Term
Intense pulsed light skin surface treatment 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intense pulsed light skin surface treatment system

MDElite iProX by MDElite Laser and Aesthetic, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intense pulsed light skin surface treatment system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MDElite Laser and Aesthetic, LLC

Sources (1)

  • FDA UDI 53d5865e-c9a5-426b-a395-5fec6d5943d2 33 fields · synced May 30, 2026