FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
K Number: K253837
·
Decision May 7, 2026
Classifications
1
FEI Numbers
29
Registration Numbers
30
Same Product Code
65
Applicant Total
17
Review Days
157
Basic Information
- Device Name
- SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
- K Number
- K253837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heidelberg Engineering GmbH
- Date Received
- December 1, 2025
- Decision Date
- May 7, 2026
- Product Code
- OBO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | FDA class 2 | Ophthalmic |
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Other Clearances by Heidelberg Engineering GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K250868 | SPECTRALIS HRA+OCT and variants | May 12, 2025 | Substantially Equivalent |
| K240924 | Anterion | Dec 13, 2024 | Substantially Equivalent |
| K241163 | SPECTRALIS with Flex Module | Oct 11, 2024 | Substantially Equivalent |
| K240221 | SPECTRALIS HRA+OCT and variants | Jul 1, 2024 | Substantially Equivalent |
| K223557 | SPECTRALIS HRA+OCT and variants | Oct 20, 2023 | Substantially Equivalent |
| K230897 | Anterion | Oct 11, 2023 | Substantially Equivalent |
| K211817 | Anterion | Nov 5, 2021 | Substantially Equivalent |
| K201252 | Spectralis HRA+OCT and variants | Sep 9, 2020 | Substantially Equivalent |
| K192391 | Spectralis HRA+OCT and Variants | Sep 26, 2019 | Substantially Equivalent |
| K182569 | Spectralis HRA+OCT and variants with High Magnification Module | Oct 18, 2018 | Substantially Equivalent |