Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)— 510(k) K240169
Substantially EquivalentBausch and Lomb, Incorporated
FDA 510(k) clearance K240169 for Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455), Substantially Equivalent on 2024-07-26. Applicant: Bausch and Lomb, Incorporated. Device class: 2.
Clearance details
- Applicant
- Bausch and Lomb, Incorporated
- 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
- St. Louis, MO, US
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)
- K250501 — System Sophi
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More clearances from Bausch and Lomb, Incorporated
view allAdverse 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.