CAPRI— 510(k) K254271
Substantially EquivalentORO Co., Ltd.
FDA 510(k) clearance K254271 for CAPRI, Substantially Equivalent on 2026-02-26. Applicant: ORO Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- ORO 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
- Gimpo-Si, KR
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)
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.