Decision Date2024-06-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Faros Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Oertli Instrumente AG. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K233398. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Faros Surgical System?
Faros Surgical System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Oertli Instrumente AG. The 510(k) number is K233398.
When did Faros Surgical System receive FDA 510(k) clearance?
Faros Surgical System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K233398.
Who is the listed applicant for Faros Surgical System?
The FDA 510(k) record lists Oertli Instrumente AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Faros Surgical System?
The FDA product code for Faros Surgical System is HQC.
Related Devices (Code: HQC)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated
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.