Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.Q-Switched Nd: YAG Laser Systems
Shanghai Apolo Medical Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260256
- Device name
- Q-Switched Nd: YAG Laser Systems
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2026-01-28
- Decision date
- 2026-05-04
- Submission type
- Traditional
- Technology type
- Q-Switched(unclassified)
- Clinical applications
- Pigment treatmentVascular treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Predicate devices
0No predicate K numbers were extracted
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Cited as predicate
0No later 510(k)s cite this device yet
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