← Back to catalogue

OptiScan

FDA UDI

Class II (US FDA UDI)

by Quanta System Spa

Identity

Trade Name
OptiScan FDA UDI
Generic Name
Skin laser scanner FDA UDI
Device Name
to be used with Youlaser CO2 FDA UDI
Model / Reference
OAM001885 FDA UDI
Description
to be used with Youlaser CO2 FDA UDI

Identifiers

Primary DI / UDI-DI
08059173390489 FDA UDI
510(k) Number
K182669 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Skin laser scanner 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: Skin laser scanner

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

Similar devices

Also classified as Skin laser scanner.

Cleared under the same submission

K182669 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
Quanta System Spa

Sources (1)

  • FDA UDI ca39f9a8-2113-4e2c-965e-93ef3cfc2cb8 34 fields · synced May 30, 2026