Drolite(Tm) Light Source
FDA 510(k) K913273 · Vision Medical, Inc.
510(k) numberK913273
Submission
- Device name
- Drolite(Tm) Light Source
- Applicant
- Vision Medical, Inc.
Fremont, CA, US - Received
- July 23, 1991
- Decision date
- December 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HJM – Transilluminator, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1945
- Specialty
- Ophthalmic
Other 510(k)s with product code HJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972506 | Infinitech Bullet Endo Illuminated Pick ManipulatorHJM · Traditional | Infinitech, Inc. | 10/01/1997SE |
| K950529 | Peregrine Diffusion Light PipeHJM · Traditional | Peregrine Surgical , Ltd. | 06/07/1995SE |
| K945877 | Weco Endoscopic Systems with Fiber Optic LightHJM · Traditional | Wells Johnson Co. | 03/02/1995SE |
| K931072 | HGM Illuminating/Aspirating Endoocular ProbeHJM · Traditional | Hgm, Inc. | 11/10/1994SE |
| K933445 | DPS 100 Multiport Illumination System (Mis)HJM · Traditional | Storz Instrument Co. | 09/23/1994SE |
| K940393 | Peregrine Wide Angle Light PipeHJM · Traditional | Peregrine Surgical , Ltd. | 09/02/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | Visitec Co. | 05/17/1994SE |
| K894513 | Diathron(R) Diathermy UnitHJM · Traditional | Intl. Ophthalmic Industries Corp. | 10/31/1989SE |
| K893170 | Vista Finoff Transilluminator (Ac-Powered)HJM · Traditional | Keeler Instruments, Inc. | 06/05/1989SE |
| K812949 | Rmi Transilluminator, Model 292HJM · Traditional | Radiation Measurements, Inc. | 12/02/1981SE |
More from Radiation Measurements, Inc.
Questions and answers
When was Drolite(Tm) Light Source cleared by the FDA?
Drolite(Tm) Light Source (K913273) received a 510(k) decision of Substantially Equivalent on December 4, 1991, 134 days after the submission was received.
What is the product code of K913273?
The FDA product code is HJM – Transilluminator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1945.