Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module

K-Number: K253837 · 2026-05-07

ApplicantHeidelberg Engineering GmbH
Decision Date2026-05-07
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module is a medical device manufactured by Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2026-05-07 under approval number K253837. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module?

SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module is a medical device that received FDA 510(k) clearance on 2026-05-07. It is manufactured by Heidelberg Engineering GmbH. The 510(k) number is K253837.

When was SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module approved by the FDA?

SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module received FDA 510(k) clearance on 2026-05-07, under approval number K253837.

What company makes SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module?

SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module is manufactured by Heidelberg Engineering GmbH.

What is the FDA product code for SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module?

The FDA product code for SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module is OBO.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑