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Nordlys System

FDA UDI

Class II (US FDA UDI)

by Candela Corporation

Identity

Trade Name
Nordlys System FDA UDI
Generic Name
Multi-modality skin surface treatment system generator FDA UDI
Device Name
Nordlys System - 200-240V China configuration FDA UDI
Model / Reference
9SYS7751-203 FDA UDI
Description
Nordlys System - 200-240V China configuration FDA UDI

Identifiers

Primary DI / UDI-DI
00817495023458 FDA UDI
510(k) Number
K150907 FDA UDI
K212492 FDA UDI
FDA Product Code
GEX FDA UDI
ONF FDA UDI
GMDN Term
Multi-modality skin surface treatment system generator 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

Yes

FDA UDI

Category: Multi-modality skin surface treatment system generator

Nordlys System by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality skin surface treatment system generator.

Cleared under the same submission

K150907 also covers:

K212492 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Candela Corporation

Sources (1)

  • FDA UDI 353904ad-19bb-478a-b5f9-cbf894935a54 35 fields · synced Jun 8, 2026