Product areas
FDA product code distribution
Shanghai Apolo Medical Technology Co., Ltd.
Country / region:China (CN)
510(k) submissions
9
Filtered: GEX
Latest clearance
2026-05-04
Product codes
1
GEX
510(k) submissions
9 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K260256 | Q-Switched Nd: YAG Laser Systems | GEX | Class 2 | 2026-05-04 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | GEX | Class 2 | 2026-04-09 |
| K203395 | Platform treatment system | GEX | Class 2 | 2022-01-28 |
| K201109 | CO2 Laser Therapy System | GEX | Class 2 | 2020-07-15 |
| K200116 | PicoSecond Nd: YAG Laser System | GEX | Class 2 | 2020-05-28 |
| K200118 | Diode Laser Therapy Device | GEX | Class 2 | 2020-04-17 |
| K191349 | 980nm Diode Laser Therapy Device | GEX | Class 2 | 2019-08-16 |
| K190938 | Phototherapy System | GEX | Class 2 | 2019-06-26 |
| K190936 | Q-Switched Nd: YAG Laser System | GEX | Class 2 | 2019-06-17 |
Company profile
- Canonical name
- Shanghai Apolo Medical Technology Co., Ltd.
- Country
- China(CN)
Cited predicates
16- K200116
PicoSecond Nd: YAG Laser System
—
- K234104
PICOANDY (Q-Switched Nd:YAG Laser)
- K241144
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
- K072564
—
—
Not ingested - K192856
MT One
- K200746
—
—
Not ingested - K133895
—
—
Not ingested - K162169
EdgeOne CO2 Laser
- K172193
Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
- K113700
—
—
Not ingested - K173700
PICOPLUS Laser System
- K191683
—
—
Not ingested - K191685
PicoWay Laser System
- K151890
Medical Diode Laser Systems
- K120460
—
—
Not ingested - K113588
—
—
Not ingested
Shanghai Apolo Medical Technology Co., Ltd. references 16 predicate/reference devices
Cited as predicate
18- K260017
Picosecond Nd:YAG Laser Systems (Model: HS-298)
- K252447
Picosecond laser device (BMPS4)
- K252345
Picosecond Laser Device (PF131-BI)
- K250998
CO2 Laser Therapy System (Model: LFS-D9U)
- K250465
CO2 Laser Machine (Lume)
- K250041
Medical Picosecond ND: YAG Laser System (PZ-6)
- K243993
Photon Therapy Apparatus (BL-10)
- K240474
Multi-function Platform Systems (BL-M10)
- K240474
Multi-function Platform Systems (BL-M10)
- K240118
Picosecond Nd:YAG Laser System
- K233077
FlashHeal 2 (FlashHeal 2.0)
- K222751
LED Light Therapy Device, KN-7000L
- K221597
CO2 Laser System
- K220268
Picosecond Laser System (Model PS10-A and PS10-B)
- K212127
Picocaremajesty
- K202758
Nd: YAG Laser Therapy Systems HM-YL900
- K200751
Photodynamic Therapy (PDT) Equipment
- K200659
Dermalux Tri-Wave MD
18 submissions cite Shanghai Apolo Medical Technology Co., Ltd. as a predicate