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)

HP-OCT (HP-OCT)

K-Number: K231760 · 2024-03-08

ApplicantCylite Pty. , Ltd.
Decision Date2024-03-08
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HP-OCT (HP-OCT) is a medical device manufactured by Cylite Pty. , Ltd.. It received FDA 510(k) clearance on 2024-03-08 under approval number K231760. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HP-OCT (HP-OCT)?

HP-OCT (HP-OCT) is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Cylite Pty. , Ltd.. The 510(k) number is K231760.

When was HP-OCT (HP-OCT) approved by the FDA?

HP-OCT (HP-OCT) received FDA 510(k) clearance on 2024-03-08, under approval number K231760.

What company makes HP-OCT (HP-OCT)?

HP-OCT (HP-OCT) is manufactured by Cylite Pty. , Ltd..

What is the FDA product code for HP-OCT (HP-OCT)?

The FDA product code for HP-OCT (HP-OCT) is HJO.

Other Devices by Cylite Pty. , Ltd.

K252633UNITY DX (UDX)

Related Devices (Code: HJO)

K161972Slit Lamp SL-D301Topcon Corporation K160327ALADDIN HW3.0Visia Imaging S.R.L. K153545Portable Slit LampShanghai Bolan Optical-Electric Co., Ltd. K152535Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd. K152429Slit Lamp MicroscopeShanghai Mediworks Precision Instruments Co. , Ltd. K171877SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T Co., Ltd.

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.

↑