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.
Summary
ORO filed a device named only CAPRI under product code GEX, powered laser surgical instrument. The record doesn't describe it beyond that name and code name.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
ORO filed from Gimpo-Si, South Korea. The decision came 58 calendar days after FDA received it (December 30, 2025 to February 26, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- ORO Co., Ltd.
- Product code
- Product 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 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.