Spectralis 86549
by Heidelberg Engineering GmbH
Spectralis 86549 is a Class II device made by Heidelberg Engineering GmbH, cleared under FDA 510(k) K253837 on 7 May 2026 (1 earlier submission) and listed in FDA GUDID since 24 Mar 2025 (UDI-DI 04059237000235), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253837 | Date7 May 2026 | StatusActive |
| United States | GUDID listing | Number04059237000235 | Date24 Mar 2025 | StatusListed |
Official records
- AccessGUDID record 04059237000235
- FDA 510(k) database K253837
- FDA 510(k) database K241163
Across registries
- FDA 510(k) K253837 decided 7 May 2026 Active
- FDA GUDID UDI-DI 04059237000235 listed 24 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K241163
- Listed FDA GUDID 04059237000235
- Cleared FDA 510(k) K253837
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spectralis
- Generic name
- Scanning-laser retinal imaging system
- Model / Ref / Catalog
- 86549
- Primary DI / UDI-DI
- 04059237000235
- FDA product code
- OBO, MYC
- GMDN term
- Scanning-laser retinal imaging system
- Device class
- Class II
- Regulation number
- 886.1570
- GUDID distribution status
- In Commercial Distribution
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