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PALLAS 308/311 Solid-State UV Laser System

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

4
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Cited as predicate

2
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Device details

FDA 510(k) registration fields

K number
K172639
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
2017-09-01
Decision date
2017-11-03
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Pigment treatmentVascular treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

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

Intended Use

UVB phototherapy for 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 the 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 06:00:49 UTC

Predicate devices

4

K172639 references 4 predicate/reference devices

Cited as predicate

2

2 submissions cite K172639 as a predicate