HJM
12 FDA 510(k) clearances · Product code
120 daysmedian time to decision
437 days90th percentile
12clearances measured
FDA profile
- Official device name
- Transilluminator, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1945
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1992: 1 · 1996: 1
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 |
|---|---|---|
| INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR (K972506) | Infinitech, Inc. | 1997-10-01 |
| PEREGRINE DIFFUSION LIGHT PIPE (K950529) | Peregrine Surgical , Ltd. | 1995-06-07 |
| WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (K945877) | Wells Johnson Co. | 1995-03-02 |
| HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE (K931072) | Hgm, Inc. | 1994-11-10 |
| DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) (K933445) | Storz Instrument Co. | 1994-09-23 |
| PEREGRINE WIDE ANGLE LIGHT PIPE (K940393) | Peregrine Surgical , Ltd. | 1994-09-02 |
| FIBEROPTIC ILLUMINATED INSTRUMENTS (K934269) | Visitec Co. | 1994-05-17 |
| DROLITE(TM) LIGHT SOURCE (K913273) | Vision Medical, Inc. | 1991-12-04 |
| DIATHRON(R) DIATHERMY UNIT (K894513) | Intl. Ophthalmic Industries Corp. | 1989-10-31 |
| VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) (K893170) | Keeler Instruments, Inc. | 1989-06-05 |
| RMI TRANSILLUMINATOR, MODEL 292 (K812949) | Radiation Measurements, Inc. | 1981-12-02 |
| RMI TRANSILLUMINATION LIGHT METER #295 (K811108) | Radiation Measurements, Inc. | 1981-07-01 |
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Every clearance here is in the API, with alerts when new ones post.