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

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Product code

GEX
21 CFR 878.4810

Predicate devices

2

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

2

K252732 references 2 predicate/reference devices

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