HKN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Refractor, Manual, Non-Powered, Including Phoropter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1770
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2014: 14 · 2017: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COMPREHENSIVE PHOROPTER, MDR-680 (K936205) | Canon USA, Inc. | 1994-09-28 |
| WOODLYN CLASSIC REFRACTOR, PHOROPTOR (K874900) | Woodlyn, Inc. | 1987-12-23 |
| FUL-VUE (K782118) | American Optical Corp. | 1979-01-26 |
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Every clearance here is in the API, with alerts when new ones post.