P200MAAF

510(k) Number

K102492 ↗

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

• Panoramic 200A

  Class II

  FDA 510(k) K042001 Active Cleared 7 Oct 2004

• OptosAdvance 4.0 Software

  Class II

  CE/MDR FDA 510(k) K162039 Active Cleared 8 Feb 2017

• PANORAMIC200 Ophthalmoscope

  Class II

  FDA 510(k) K983999 Active Cleared 3 Feb 1999

• Daytona ICG (P200TICG)

  Class II

  CE/MDR FDA 510(k) K134039 Active Cleared 11 Apr 2014

• Optos Oct/Slo Microperimeter

  Class II

  FDA 510(k) K121043 Active Cleared 22 Feb 2013

• Optos Limited Panoramic 200CAF

  Class II

  FDA 510(k) K100644 Active Cleared 15 Jul 2010

See all devices from Optos plc →

• What is the P200MAAF used for?

  The P200MAAF is a scanning laser ophthalmoscope used for imaging the retina in ophthalmic settings, as defined by its device type and intended use in retinal imaging procedures.

• Is the P200MAAF a reusable or single-use device?

  The P200MAAF is supplied as a reusable device, meaning it is designed for multiple uses after appropriate cleaning and reprocessing between patients, as stated in the device description.

• What regulatory pathway was used for the P200MAAF?

  The P200MAAF received FDA 510(k) clearance under submission number K102492, indicating it was found substantially equivalent to a legally marketed predicate device, as specified in the authorization and decision fields.

• When was the P200MAAF cleared by the FDA?

  The P200MAAF received FDA 510(k) clearance on September 30, 2010, as documented in the decision_date field of the device data.

• What class is the P200MAAF under FDA regulations?

  The P200MAAF is classified as a Class II medical device under FDA regulation number 886.1570, as explicitly stated in the description and confirmed by the device_class field in openfda.