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PALLAS Handpiece

FDA UDI

Class II (US FDA UDI)

by Laseroptek Co., Ltd

Identity

Trade Name
PALLAS Handpiece FDA UDI
Generic Name
Dermatological excimer laser system FDA UDI
Device Name
PALLAS Handpiece 12x12mm FDA UDI
Model / Reference
PALLAS Handpiece FDA UDI
Description
PALLAS Handpiece 12x12mm FDA UDI

Identifiers

Primary DI / UDI-DI
08800035500900 FDA UDI
510(k) Number
K191501 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Dermatological excimer 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

Category: Dermatological excimer laser system

PALLAS Handpiece by Laseroptek Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatological excimer laser system.

Cleared under the same submission

K191501 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Laseroptek Co., Ltd

Sources (1)

  • FDA UDI da9c78be-20a8-48cc-b974-277021208c79 35 fields · synced May 30, 2026