Modified Site Fiber Optic Module for Ophthal. Use
FDA 510(k) K883480 · Site Microsurgical Systems, Inc.
510(k) numberK883480
Submission
- Device name
- Modified Site Fiber Optic Module for Ophthal. Use
- Applicant
- Site Microsurgical Systems, Inc.
Horsham, PA, US - Received
- August 16, 1988
- Decision date
- August 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCT – Headlight, Fiberoptic Focusing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4335
- Specialty
- Ophthalmic
Other 510(k)s with product code FCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960767 | Light CommanderFCT · Traditional | Scieran Technologies, Inc. | 08/26/1996SE |
| K924198 | Modified Site Fiber Optic ModuleFCT · Traditional | Chiron Vision Corp. | 11/23/1992SE |
| K802770 | Fiber Optic Headlight #60-0766766FCT · Traditional | Aspen Laboratories, Inc. | 12/11/1980SE |
| K802769 | Fiber Optic Headlight #60-0765FCT · Traditional | Aspen Laboratories, Inc. | 12/11/1980SE |
| K780433 | Fiber Optic Adjustable HeadlightFCT · Traditional | Cameron-Miller, Inc. | 06/13/1978SE |
More from Cameron-Miller, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925828 | Modified Site TXR SystemsHQC · Traditional | 02/16/1994SE |
| K925921 | Modified Site Disposable Diaphragm CassetteKYG · Traditional | 12/06/1993SE |
| K931866 | Site's CD II Phacoemulsification HandpieceHQC · Traditional | 11/12/1993SE |
| K921135 | Iolab Power I.V. PoleHQC · Traditional | 06/03/1992SE |
| K920582 | 180 Tip, 1/A Handpiece .3MM End Opening for Opht.HQE · Traditional | 05/08/1992SE |
| K912902 | Phacoemulsification System for Ophthalmic UseHQC · Traditional | 12/17/1991SE |
| K912739 | Site 90 Tip, I/A Handpiece .3MM Side Open/Opth UseHQC · Traditional | 08/28/1991SE |
| K910980 | Site 20 Gauge Reusable Fiber Optic CableHJO · Traditional | 05/22/1991SE |
| K905620 | Modified Site Peristaltic FootswitchEBW · Traditional | 02/27/1991SE |
| K904183 | Site Phacoemulsification HandpieceHQC · Traditional | 12/05/1990SE |
Questions and answers
When was Modified Site Fiber Optic Module for Ophthal. Use cleared by the FDA?
Modified Site Fiber Optic Module for Ophthal. Use (K883480) received a 510(k) decision of Substantially Equivalent on August 24, 1988, 8 days after the submission was received.
What is the product code of K883480?
The FDA product code is FCT – Headlight, Fiberoptic Focusing, a Class II (moderate risk) device regulated under 21 CFR 886.4335.