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

Company

Shanghai Apolo Medical Technology Co., Ltd.

China (CN)

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
Company: Shanghai Apolo Medical Technology Co., Ltd.
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

0

No predicate K numbers were extracted

The Summary PDF may not be parsed yet, or this submission may not cite predicate devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K260256 as a predicate