Transilluminator, Ac-Powered
The AC-Powered Ophthalmic Transilluminator is an electrically powered light source used to illuminate ocular and periocular structures by transmitting light through tissues, aiding in the detection of masses, cysts, or tumors within the eye or orbit. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence before marketing. The product code is HJM, regulated under 21 CFR 886.1945, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HJM
- Device Class
- FDA class 2
- Regulation Number
- 886.1945
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972506 | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | Oct 01, 1997 | Substantially Equivalent | Infinitech, Inc. |
| K950529 | PEREGRINE DIFFUSION LIGHT PIPE | Jun 07, 1995 | Substantially Equivalent | Peregrine Surgical , Ltd. |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Mar 02, 1995 | Substantially Equivalent | Wells Johnson Co. |
| K931072 | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | Nov 10, 1994 | Substantially Equivalent | Hgm, Inc. |
| K933445 | DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) | Sep 23, 1994 | Substantially Equivalent | Storz Instrument Co. |
| K940393 | PEREGRINE WIDE ANGLE LIGHT PIPE | Sep 02, 1994 | Substantially Equivalent | Peregrine Surgical , Ltd. |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | May 17, 1994 | Substantially Equivalent | Visitec Co. |
| K913273 | DROLITE(TM) LIGHT SOURCE | Dec 04, 1991 | Substantially Equivalent | Vision Medical, Inc. |
| K894513 | DIATHRON(R) DIATHERMY UNIT | Oct 31, 1989 | Substantially Equivalent | Intl. Ophthalmic Industries Corp. |
| K893170 | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) | Jun 05, 1989 | Substantially Equivalent | Keeler Instruments, Inc. |
| K812949 | RMI TRANSILLUMINATOR, MODEL 292 | Dec 02, 1981 | Substantially Equivalent | Radiation Measurements, Inc. |
| K811108 | RMI TRANSILLUMINATION LIGHT METER #295 | Jul 01, 1981 | Substantially Equivalent | Radiation Measurements, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.