Manufacturer
Laseroptek Co., Ltd.PALLAS 308/311 Solid-State UV Laser System
Country / Region:Korea, Republic of (KR)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
1PALLAS 308/311 Solid-State UV Laser System
K191501 references 1 predicate/reference device
Cited as predicate
1PALLAS Premium
1 submission cite K191501 as a predicate