FDA 510(k)

CENTURION Vision System (Active SentryTM)

K-번호: K161794 · 2017-04-14

결정일2017-04-14

제품 코드HQC

자문 위원회OP

결정Substantially Equivalent

기기 요약

CENTURION Vision System (Active SentryTM) is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Research, Ltd.. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K161794. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CENTURION Vision System (Active SentryTM)?

CENTURION Vision System (Active SentryTM) is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Alcon Research, Ltd.. The 510(k) number is K161794.

When did CENTURION Vision System (Active SentryTM) receive FDA 510(k) clearance?

CENTURION Vision System (Active SentryTM) received FDA 510(k) clearance on 2017-04-14, under 510(k) number K161794.

Who is the listed applicant for CENTURION Vision System (Active SentryTM)?

The FDA 510(k) record lists Alcon Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTURION Vision System (Active SentryTM)?

The FDA product code for CENTURION Vision System (Active SentryTM) is HQC.

Alcon Research, Ltd.를 신청인으로 등재한 기타 기록

K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+

관련 기기 (코드: HQC)

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 Lomb K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 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

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