Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

L12 LED Light Source with AIM

K-Number: K230754 · 2023-04-11

ApplicantStryker
Decision Date2023-04-11
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

L12 LED Light Source with AIM is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2023-04-11 under approval number K230754. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L12 LED Light Source with AIM?

L12 LED Light Source with AIM is a medical device that received FDA 510(k) clearance on 2023-04-11. It is manufactured by Stryker. The 510(k) number is K230754.

When was L12 LED Light Source with AIM approved by the FDA?

L12 LED Light Source with AIM received FDA 510(k) clearance on 2023-04-11, under approval number K230754.

What company makes L12 LED Light Source with AIM?

L12 LED Light Source with AIM is manufactured by Stryker.

What is the FDA product code for L12 LED Light Source with AIM?

The FDA product code for L12 LED Light Source with AIM is OWN.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT05964907 Optimizing Phototesting and Investigating Photobiology of Visible Light ACTIVE_NOT_RECRUITING NCT07557550 Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients RECRUITING

Other Devices by Stryker

K161821Stryker Universal Mesh K162310XBraid TT Suture Tape K162262Tritanium® PL Cage K160955Tritanium® PL Cage K153248PEEK Customized Cranial Implant K153508Stryker CMF MEDPOR Customized Implant

View all 64 devices →

Related Devices (Code: OWN)

K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑