L12 LED Light Source with AIM
FDA 510(k) K230754 · Stryker
510(k) numberK230754
Submission
- Device name
- L12 LED Light Source with AIM
- Applicant
- Stryker
San Jose, CA, US - Received
- March 17, 2023
- Decision date
- April 11, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 L12 LED Light Source with AIM cleared by the FDA?
L12 LED Light Source with AIM (K230754) received a 510(k) decision of Substantially Equivalent on April 11, 2023, 25 days after the submission was received.
What is the product code of K230754?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.