TearView— 510(k) K253176
Substantially EquivalentBeyond 700 Pty, Ltd.
FDA 510(k) clearance K253176 for TearView, Substantially Equivalent on 2026-06-22. Applicant: Beyond 700 Pty, Ltd.. Device class: 2.
Summary
TearView from Beyond 700 is filed under HKI, AC-powered ophthalmic cameras. The record doesn't describe the camera beyond its name and the code name.
Class II, 21 CFR 886.1120. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Beyond 700 filed from Castle Hill, Australia. The decision came 269 calendar days after FDA received it (September 26, 2025 to June 22, 2026).
Clearance details
- Applicant
- Beyond 700 Pty, Ltd.
- Product code
- Product code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castle Hill, AU
Recent devices under product code HKI
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