HJN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Transilluminator, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1945
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 2005: 3
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 |
|---|---|---|
| VENOSCOPE (K941035) | Trinity Partners, LLC | 1994-05-16 |
| LULMITEX NEONATAL TRANSILLUMINATOR (K912747) | Lumitex, Inc. | 1991-12-24 |
| SYLVAN PEDIASCAN 200 TRANSILLUMINATOR (K901309) | Sylvan Corp. | 1990-05-24 |
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Every clearance here is in the API, with alerts when new ones post.