Daytona ICG (P200TICG)

510(k) Number

K134039 ↗

FDA Product Code

MYC

FDA applicant

Optos Plc.

Device Class

Class II

Regulation

21 CFR Part 886.1570

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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• Is the Daytona ICG (P200TICG) a single-use device or reusable, and what sterilization requirements apply?

  The Daytona ICG (P200TICG) is designed as a reusable medical instrument, meaning it must be properly sterilized between uses in clinical settings. Since it is classified as a Class II device under FDA regulations, standard sterilization protocols (such as autoclaving or chemical sterilization) must be followed to ensure safety and prevent cross-contamination. Always adhere to manufacturer guidelines and facility infection control policies.

• What is the primary field of use for the Daytona ICG (P200TICG), and who is it intended for?

  The Daytona ICG (P200TICG) is intended for clinical ophthalmic settings and is specifically designed for use by trained eye care professionals. It employs an 802 nm infrared laser to capture high-resolution retinal images in a 200-degree field of view, enabling detailed retinal visualization for diagnostic and screening purposes. It is not intended for home use or non-professional administration.

• How is the regulatory status of this device determined, and what does that mean for purchasing or use?

  The Daytona ICG (P200TICG) holds FDA 510(k) clearance (K134039) and is authorized under the EU Medical Device Regulation (MDR). This means it has undergone a premarket review to demonstrate substantial equivalence to a predicate device (as determined by the FDA’s Ophthalmic Advisory Committee) and meets EU safety and performance requirements. Purchasers should confirm compliance with local regulatory requirements before use, though the device itself is not intended for any specific clinical indication beyond retinal imaging.

• Does the Daytona ICG (P200TICG) come in multiple sizes or models, or is it a single configuration?

  The provided data does not specify multiple sizes or models for the Daytona ICG (P200TICG). It is described as a single device configuration—a wide-field scanning laser ophthalmoscope (SLO) with a fixed 200-degree imaging field. If additional variants exist (e.g., different imaging angles or software versions), they are not detailed in the available information. For exact specifications, consult the manufacturer’s technical documentation.