Picosecond Nd:YAG Laser Systems (Model: HS-298)— 510(k) K260017
Substantially EquivalentShanghai Apolo Medical Technology Co., Ltd.
FDA 510(k) clearance K260017 for Picosecond Nd:YAG Laser Systems (Model: HS-298), Substantially Equivalent on 2026-04-09. Applicant: Shanghai Apolo Medical Technology Co., Ltd.. Device class: 2.
Summary
The Picosecond Nd:YAG Laser System (Model HS-298) is a cosmetic dermatology laser — product code GEX covers laser and intense-pulsed-light devices for dermatologic and aesthetic indications. Picosecond Nd:YAG systems are widely used for tattoo removal and pigmented-lesion treatment; the category is crowded with predicates from Cynosure, Quanta, Lutronic, and others.
General, Plastic Surgery panel, Traditional 510(k). GEX is one of FDA's highest-volume product codes with a mature predicate set — picosecond laser clearances tend to be relatively predictable as long as the technological comparison to a picosecond predicate holds.
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Clearance details
- Applicant
- Shanghai Apolo Medical Technology Co., Ltd.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code GEX
view all- K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
- K261964 — ECHOLASER X4
- K262070 — Diode Laser Therapy Systems (DL612A)
- K261841 — Q Switched Nd:YAG Laser machine (QLQW-01)
- K261221 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
More clearances from Shanghai Apolo Medical Technology Co., Ltd.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.