Manufacturer
Laseroptek Co., Ltd.PALLAS Premium
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
2PALLAS 308/311 Solid-State UV Laser System
XTRAC Momentum Excimer Laser System
K223588 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K223588 as a predicate