Lightwear(Tm) Syst (Lightwear Headlight Clip/Headband)
FDA 510(k) K936048 · Cogent Light Technologies, Inc.
510(k) numberK936048
Submission
- Device name
- Lightwear(Tm) Syst (Lightwear Headlight Clip/Headband)
- Applicant
- Cogent Light Technologies, Inc.
Valencia, CA, US - Received
- December 20, 1993
- Decision date
- March 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With…FST · Traditional | Innovasis, Inc. | 06/30/2020SE |
| K141330 | Endo-CordFST · Traditional | Enroxtech, Inc. | 12/15/2014SE |
| K122637 | Lite Decompression System- Light Cable Model 48089999FST · Traditional | Stryker Spine | 11/01/2012SE |
| K113697 | Eigr Surgical Illumination SystemFST · Special | Invuity, Inc. | 02/10/2012SE |
| K113330 | CablecapFST · Traditional | Sensormed | 01/12/2012SE |
| K102266 | Isoled Ac-Powered LED Headlight SystemFST · Traditional | Isolux, LLC | 09/24/2010SE |
| K101496 | Cablecap Model: WLF, STZ, AcmFST · Traditional | Sensormed | 09/14/2010SE |
| K100388 | 21ST Century Centurion Exceled and System Two LED Lighting SystemsFST · Traditional | Medical Illumination International, Inc. | 06/22/2010SE |
| K100395 | Harmony Vled Surgical Lightning SystemFST · Special | STERIS Corporation | 03/17/2010SE |
| K093386 | Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FSTFST · Traditional | Bfw, Inc. | 01/28/2010SE |
More from Bfw, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001698 | Micro Link Endoscopic Fiber Cable, Model B1-90159FFS · Traditional | 07/17/2000SE |
| K983714 | Solartec Source 270, Model # 90123FFS · Traditional | 12/23/1998SE |
| K971057 | Cogenlight Technologies XLS Illuminator SystemGCT · Traditional | 03/28/1997SE |
| K933405 | Cogent Light Illuminator 10010 Xenon Light SourceGCT · Traditional | 02/18/1994SE |
Questions and answers
When was Lightwear(Tm) Syst (Lightwear Headlight Clip/Headband) cleared by the FDA?
Lightwear(Tm) Syst (Lightwear Headlight Clip/Headband) (K936048) received a 510(k) decision of Substantially Equivalent on March 10, 1994, 80 days after the submission was received.
What is the product code of K936048?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.