System Sophi— 510(k) K250501
Substantially EquivalentThis AG
FDA 510(k) clearance K250501 for System Sophi, Substantially Equivalent on 2025-11-14. Applicant: This AG. Device class: 2.
Clearance details
- Applicant
- This AG
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Heerbrugg, CH
Recent devices under product code HQC
view all- K261264 — Stellaris Elite vision enhancement system +7 more
- K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- K243395 — MICOR 700 with Auto I/A
- K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
- K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.