← Back to catalogue

Diode 3D Trio 4cm HP for Soprano Titanium

FDA UDI

Class II (US FDA UDI)

by Alma Lasers Ltd.

Identity

Trade Name
Diode 3D Trio 4cm HP for Soprano Titanium FDA UDI
Generic Name
Dermatological diode laser system FDA UDI
Model / Reference
1 FDA UDI

Identifiers

Catalog Number
AASP30111208 FDA UDI
Primary DI / UDI-DI
17290110121812 FDA UDI
510(k) Number
K222064 FDA UDI
FDA Product Code
GEX FDA UDI
ILY FDA UDI
GMDN Term
Dermatological diode laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
890.5500 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: Dermatological diode laser systemIntense pulsed light skin surface treatment system

Diode 3D Trio 4cm HP for Soprano Titanium by Alma Lasers Ltd. — 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

K222064 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alma Lasers Ltd.

Sources (1)

  • FDA UDI 59fa0c49-ba5c-4a8b-9d0b-30198c7f0b69 34 fields · synced May 30, 2026