Product code HJM— Ophthalmic
DIATHRON(R) DIATHERMY UNIT
- Classification name
- Transilluminator, Ac-Powered
- Device class
- Class 2
- Regulation
- 21 CFR 886.1945
- Advisory panel
- Ophthalmic
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code HJM
FDA has cleared devices under product code HJM between 1981 and 1997, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1997
- 1995
- 1994
- 1991
- 1989
- 1981
Top applicants under product code HJM
Recent clearances under product code HJM
- K972506 — INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
- K950529 — PEREGRINE DIFFUSION LIGHT PIPE
- K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT
- K931072 — HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
- K933445 — DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)
- K940393 — PEREGRINE WIDE ANGLE LIGHT PIPE
- K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS
- K913273 — DROLITE(TM) LIGHT SOURCE
- K894513 — DIATHRON(R) DIATHERMY UNIT
- K893170 — VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
- K812949 — RMI TRANSILLUMINATOR, MODEL 292
- K811108 — RMI TRANSILLUMINATION LIGHT METER #295
Data sourced from openFDA. This site is unofficial and independent of the FDA.