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Del Sol Blue Light Therapy System

FDA UDI

Class II (US FDA UDI)

by Hydrafacial LLC

Identity

Trade Name
Del Sol Blue Light Therapy System FDA UDI
Generic Name
Skin photodynamic therapy/phototherapy lamp FDA UDI
Device Name
Blue LED Handpiece with Power Supply FDA UDI
Model / Reference
Power Supply FDA UDI
Description
Blue LED Handpiece with Power Supply FDA UDI

Identifiers

Catalog Number
70207 FDA UDI
Primary DI / UDI-DI
00850043007050 FDA UDI
510(k) Number
K061470 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Skin photodynamic therapy/phototherapy lamp 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

No

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: Skin photodynamic therapy/phototherapy lamp

Del Sol Blue Light Therapy System by Hydrafacial LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin photodynamic therapy/phototherapy lamp.

Cleared under the same submission

K061470 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hydrafacial LLC

Sources (1)

  • FDA UDI c2993143-6235-44d9-8cf9-721f16616047 36 fields · synced May 30, 2026