Manufacturer
Zhengzhou PZ Laser Slim Technology Co., Ltd.1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Country / Region:China (CN)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
- K252732
- Device name
- 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-08-28
- Decision date
- 2025-10-23
- Submission type
- Traditional
- Technology type
- Thulium fiber(AI inferred)
- Clinical applications
- Skin resurfacingPigment treatmentVascular treatmentOther
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
1927nm thulium laser system is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Intended Use
1927nm thulium laser system is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Device Description
1927nm Thulium Laser System contains a thulium-doped fiber laser module that uses a 1927nm pulsed laser output energy. The beam is directly irradiated to the treatment area through the handle and optical fiber. According to the selective light absorption theory, the 1927nm laser can be preferentially absorbed by the water in the skin, thus achieving the purpose of coagulation of soft tissue. The operator can optimize the treatment effect of each application by controlling the pulse width, distance between the dot matrices and treatment mode of the pulsed laser. There are 2 models included, PZ-DJG75-01, PZ-DJG75-02, the two models have the same intended use, mechanism of action and principle, only the step of pulse width under the dot matrix mode are different.
Summary parsed at:2026-06-01 05:24:12 UTC
Predicate devices
2Joule System
Lavieen
K252732 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 K252732 as a predicate
