ANTERION— 510(k) K261019
Substantially EquivalentHeidelberg Engineering GmbH
FDA 510(k) clearance K261019 for ANTERION, Substantially Equivalent on 2026-09-11. Applicant: Heidelberg Engineering GmbH. Device class: 2.
Summary
ANTERION is Heidelberg Engineering's anterior segment imaging platform, filed under OBO, optical coherence tomography. It images the cornea, anterior chamber, and lens for cataract, refractive, and glaucoma workups.
Class II, 21 CFR 886.1570. The Ophthalmic panel reviewed it as a Traditional 510(k). ANTERION has been sold in the US for several years, so this is almost certainly an update (most likely software or measurement modules) and not a first clearance.
Heidelberg Engineering filed from Heidelberg, Germany. Review took 168 days (March 27 to September 11, 2026). For ophthalmic imaging updates, where most of the evidence is measurement agreement with the predicate, that's a normal run.
Clearance details
- Applicant
- Heidelberg Engineering GmbH
- Product code
- Code OBO
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Heidelberg, DE
Recent devices under product code OBO
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