HJM — Transilluminator, Ac-Powered Class II
FDA product code HJM covers "Transilluminator, Ac-Powered", a Class II medical device regulated under 21 CFR 886.1945. Submissions are reviewed by the Ophthalmic panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HJM
- Device Class
- Class II
- Regulation Number
- 886.1945
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972506 | infinitech | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | October 1, 1997 |
| K950529 | peregrine surgical | PEREGRINE DIFFUSION LIGHT PIPE | June 7, 1995 |
| K945877 | wells johnson | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | March 2, 1995 |
| K931072 | hgm | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | November 10, 1994 |
| K933445 | storz instrument | DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) | September 23, 1994 |
| K940393 | peregrine surgical | PEREGRINE WIDE ANGLE LIGHT PIPE | September 2, 1994 |
| K934269 | visitec | FIBEROPTIC ILLUMINATED INSTRUMENTS | May 17, 1994 |
| K913273 | vision medical | DROLITE(TM) LIGHT SOURCE | December 4, 1991 |
| K894513 | intl. ophthalmic industries | DIATHRON(R) DIATHERMY UNIT | October 31, 1989 |
| K893170 | keeler instruments | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) | June 5, 1989 |
| K812949 | radiation measurements | RMI TRANSILLUMINATOR, MODEL 292 | December 2, 1981 |
| K811108 | radiation measurements | RMI TRANSILLUMINATION LIGHT METER #295 | July 1, 1981 |