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Luxy Hp, Starlux 500

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name
LUXY HP, STARLUX 500 FDA UDI
Generic Name
Intense pulsed light skin surface treatment system FDA UDI
Device Name
LUXY HP, STARLUX 500 FDA UDI
Model / Reference
5520-Y026 FDA UDI
Description
LUXY HP, STARLUX 500 FDA UDI

Identifiers

Primary DI / UDI-DI
00841494108557 FDA UDI
510(k) Number
K041086 FDA UDI
FDA Product Code
GEX FDA UDI
ONG 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intense pulsed light skin surface treatment system

Luxy Hp, Starlux 500 by Cynosure, 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.

Cleared under the same submission

K041086 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cynosure, LLC

Sources (1)

  • FDA UDI 6a8a62a1-55c0-474e-90af-8ae5ae98150c 34 fields · synced Jun 8, 2026