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LuxY HP, Starlux

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name
LuxY HP, Starlux FDA UDI
Generic Name
Light-energy skin surface treatment system applicator FDA UDI
Device Name
LuxY HP, Starlux FDA UDI
Model / Reference
1520-Y026 FDA UDI
Description
LuxY HP, Starlux FDA UDI

Identifiers

Primary DI / UDI-DI
00841494108007 FDA UDI
510(k) Number
K041086 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Light-energy skin surface treatment system applicator 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: Light-energy skin surface treatment system applicator

LuxY HP, Starlux by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Light-energy skin surface treatment system applicator.

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 400881a1-9269-433b-8a79-d8f8c4a65b73 34 fields · synced Jun 1, 2026