L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
FDA 510(k) K192292 · Stryker
510(k) numberK192292
Submission
- Device name
- L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
- Applicant
- Stryker
San Jose, CA, US - Received
- August 23, 2019
- Decision date
- November 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
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Questions and answers
When was L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable cleared by the FDA?
L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable (K192292) received a 510(k) decision of Substantially Equivalent on November 19, 2019, 88 days after the submission was received.
What is the product code of K192292?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.