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PALLAS Premium

Laseroptek Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Laseroptek Co., Ltd.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
View list →

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K223588
Device name
PALLAS Premium
Company
Laseroptek Co., Ltd.
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-12-01
Decision date
2023-01-26
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Pigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Intended Use

PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Device Description

This device consists of a power supply unit, a cooling system, a controller, and a laser resonator, and is controlled by a microprocessor. When electric energy pumping is applied to the flash lamp, the laser is emitted through a device laser module that oscillates a laser with a wavelength of 311nm, and the laser is radiated through the end of the optical fiber, which is a laser carrier.

Summary parsed at:2026-06-01 05:32:16 UTC

Predicate devices

2

K223588 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K223588 as a predicate