510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K250868Substantially Equivalent

SPECTRALIS HRA+OCT and variants

Heidelberg Engineering GmbH, Heidelberg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250868 is the FDA 510(k) clearance record for SPECTRALIS HRA+OCT and variants, a class II device, cleared for Heidelberg Engineering GmbH on under FDA product code OBO (Tomography, Optical Coherence). FDA's definition for product code OBO reads: "Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases". FDA records list 26 510(k) clearances for Heidelberg Engineering GmbH, from to . As of , FDA records show no recalls naming K250868.

Clearance record

Decision date
Received
(49 days to decision)
Product code
OBO Tomography, Optical Coherence
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Heidelberg Engineering GmbH Max-Jarecki-Str. 8, Heidelberg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBO

Trailing 12 months
3 clearances under product code OBO in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OBO, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260