Affirm 400

FDA 510(k) K251286 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

Substantially Equivalent

510(k) numberK251286

Submission

Device name
Affirm 400
Applicant
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
Goleta, CA, US
Received
April 25, 2025
Decision date
January 21, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QFX – Diagnostic Neurosurgical Microscope Filter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4950
Specialty
Neurology

A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.

Other 510(k)s with product code QFX

510(k)DeviceApplicantDecision
K240215Blue 400; Blue 400 SQFX · Traditional Carl Zeiss Meditec, AG06/28/2024SE
K232567Myriad SPECTRA Light SourceQFX · Traditional Nico Corporation03/14/2024SE
K211346Blue 400QFX · Traditional Carl Zeiss Meditec, AG07/22/2022SE

More from Carl Zeiss Meditec, AG

510(k)DeviceDecision
K243077Affirm 800IZI · Traditional 06/27/2025SE

Questions and answers

When was Affirm 400 cleared by the FDA?

Affirm 400 (K251286) received a 510(k) decision of Substantially Equivalent on January 21, 2026, 271 days after the submission was received.

What is the product code of K251286?

The FDA product code is QFX – Diagnostic Neurosurgical Microscope Filter, a Class II (moderate risk) device regulated under 21 CFR 882.4950.