510(k) clearance
ANTERION
- 510(k) number
- K261019
- Applicant
- Heidelberg Engineering GmbH
- Decision date
- Sep 11, 2026
- Date received
- Mar 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OBO
- Device type
- Tomography, Optical Coherence
- Device class
- Class II
- Regulation
- 21 CFR 886.1570
- Advisory committee
- Ophthalmic
- Statement or summary
- Summary
- Third party
- N
- Location
- Heidelberg, DE