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PALLAS 308/311 Solid-State UV Laser System

Laseroptek Co., Ltd.

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

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

1
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K191501
Device name
PALLAS 308/311 Solid-State UV Laser System
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
2019-06-06
Decision date
2020-01-03
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Skin resurfacing
Primary application
Skin resurfacing
Classification source
AI classified

Indications for Use

UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.

Intended Use

UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.

Device Description

Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.

Summary parsed at:2026-06-01 05:46:45 UTC

Predicate devices

1

K191501 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K191501 as a predicate