510(k) K260256
- Device
- Q-Switched Nd: YAG Laser Systems
- Applicant
- Shanghai Apolo Medical Technology Co., Ltd.
- 510(k) number
- K260256
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-04
- Date received
- 2026-01-28
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Felix Li
- Address
- Bldg. 11, Ln. 1566, Nanle Rd., Songjiang District Shanghai CN 201613 201613
FDA Registration Numbers
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Source Documents
Other 510(k) Records For Product Code GEX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | 2026-05-11 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies, Slu | 2026-05-04 |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026-04-29 |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | 2026-04-22 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026-03-31 |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026-03-28 |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | 2026-03-17 |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | 2026-03-17 |
| K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | 2026-03-11 |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-03-06 |
| K253920 | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | 2026-03-03 |