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Duality

FDA UDI

Class II (US FDA UDI)

by Quanta System Spa

Identity

Trade Name
Duality FDA UDI
Generic Name
Dermatological frequency-doubled solid-state laser system FDA UDI
Device Name
Dermatological and aesthetic laser device operating at 1064 and 532 nm. FDA UDI
Model / Reference
PCMS00354 FDA UDI
Description
Dermatological and aesthetic laser device operating at 1064 and 532 nm. FDA UDI

Identifiers

Primary DI / UDI-DI
08059173396368 FDA UDI
510(k) Number
K192160 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Dermatological frequency-doubled solid-state laser 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dermatological frequency-doubled solid-state laser system

Duality by Quanta System Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatological frequency-doubled solid-state laser system.

Cleared under the same submission

K192160 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quanta System Spa

Sources (1)

  • FDA UDI 96b36a2b-0a4c-4334-92a7-6ac2c91b056a 34 fields · synced May 30, 2026