Solartec Source 270, Model # 90123
FDA 510(k) K983714 · Cogent Light Technologies, Inc.
510(k) numberK983714
Submission
- Device name
- Solartec Source 270, Model # 90123
- Applicant
- Cogent Light Technologies, Inc.
Valencia, CA, US - Received
- October 21, 1998
- Decision date
- December 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFS – Image, Illumination, Fiberoptic, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | Cook Urological, Inc. | 11/20/2007SE |
| K061622 | PS SeriesFFS · Traditional | Photonic Optische Gerate Gesmbh & Cokg | 03/05/2007SE |
| K063309 | Tru-CableFFS · Traditional | Truphatek International, Ltd. | 01/12/2007SE |
| K061025 | Accutech Endolite ProbeFFS · Traditional | Accutech Medical Technologies, Inc. | 05/31/2006SE |
| K023633 | Sovis Optique's Endoscopic CableFFS · Traditional | Sovis Optique | 12/31/2002SE |
| K001698 | Micro Link Endoscopic Fiber Cable, Model B1-90159FFS · Traditional | Cogent Light Technologies, Inc. | 07/17/2000SE |
| K994084 | Smith & Nephew Xenon Light Sources and AccessoriesFFS · Traditional | Smith & Nephew, Inc. | 01/20/2000SE |
| K991323 | Smith & Nephew Subcutaneous IlluminatorFFS · Traditional | Smith & Nephew, Inc. | 07/06/1999SE |
| K982462 | Fiber Optic Endoillumination ProbeFFS · Traditional | Microvision, Inc. | 09/14/1998SE |
| K980636 | Fiber Optic Endoillumination ProbeFFS · Traditional | Dutch Ophthalmic USA, Inc. | 05/20/1998SE |
More from Dutch Ophthalmic USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001698 | Micro Link Endoscopic Fiber Cable, Model B1-90159FFS · Traditional | 07/17/2000SE |
| K971057 | Cogenlight Technologies XLS Illuminator SystemGCT · Traditional | 03/28/1997SE |
| K936048 | Lightwear(Tm) Syst (Lightwear Headlight Clip/Headband)FST · Traditional | 03/10/1994SE |
| K933405 | Cogent Light Illuminator 10010 Xenon Light SourceGCT · Traditional | 02/18/1994SE |
Questions and answers
When was Solartec Source 270, Model # 90123 cleared by the FDA?
Solartec Source 270, Model # 90123 (K983714) received a 510(k) decision of Substantially Equivalent on December 23, 1998, 63 days after the submission was received.
What is the product code of K983714?
The FDA product code is FFS – Image, Illumination, Fiberoptic, For Endoscope , a Class II (moderate risk) device regulated under 21 CFR 876.1500.