OCT-Camera ID 21101A3

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K200516 ↗

FDA Product Code

OBO

Device Class

Class II

Regulation

21 CFR Part 886.1570

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• OCT-Camera Open recall

  Class II

  FDA 510(k) K142953 Active Cleared 4 Mar 2015

• What clinical setting is the OCT-Camera ID 21101A3 designed for, and how does it function in that environment?

  The OCT-Camera ID 21101A3 is specifically designed for ophthalmic settings, such as eye clinics or hospitals. It functions as a non-contact imaging tool that acquires, processes, displays, and saves depth-resolved images of ocular tissue microstructure. These images help clinicians evaluate eye conditions by providing detailed visualization of the retina and other ocular structures without direct contact with the eye.

• Is the OCT-Camera ID 21101A3 a single-use or reusable device, and what does this mean for maintenance?

  The OCT-Camera ID 21101A3 is a reusable medical device, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. This design allows for cost-effective operation in clinical settings, but it also requires adherence to strict protocols to ensure sterility and functionality between uses.

• What regulatory pathway was followed for the FDA clearance of this device, and what does this classification mean for its use?

  The OCT-Camera ID 21101A3 received FDA clearance through a 510(k) submission, specifically classified as Substantially Equivalent (SESE) under the Ophthalmic advisory committee. This means the device was determined to be at least as safe and effective as a legally marketed predicate device, allowing it to enter the market without requiring a full premarket approval process. The classification under regulation number 886.1570 further confirms its alignment with FDA standards for optical coherence tomography systems.

• Does the device come with multiple models or configurations, and if so, how might this affect my purchasing decision?

  The provided data lists multiple FEI numbers (e.g., 3004441848, 3002807782), which typically correspond to different configurations, software versions, or accessory kits for the OCT-Camera ID 21101A3. While the base device itself is standardized, these variations may include updates, additional imaging modes, or compatibility with different ocular probes. When purchasing, you should confirm which specific FEI numbers align with your clinical needs, such as resolution requirements or software features, to ensure full functionality for your intended use.