510(k) K260017— Picosecond Nd:YAG Laser Systems (Model: HS-298)
Substantially EquivalentShanghai Apolo Medical Technology Co., Ltd.
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
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Adverse 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.