# K981640: S2LO

- Pathway: 510(k) (Traditional)
- Applicant: Odyssey Optical Systems, LLC
- Decided: Aug 5, 1998 after 89 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Rodenstock Scanning Laser Ophthalmoscope: named in the summary without a submission number
- (no number) Humphrey Optical Coherence Tomography Scanner: named in the summary without a submission number

## Most influential descendants
- K983999: PANORAMIC200 Opthalmoscope (1999), 13 descendants of its own
- K100644: Optos Limited Panoramic 200CAF (2010), 9 descendants of its own
- K042001: Panoramic 200A (2004), 9 descendants of its own
- K060424: Panoramic, Model 200MA (2006), 8 descendants of its own
- K102492: P200MAAF (2010), 7 descendants of its own

## Indications for use
The Odyssey Optical Systems S*LO is indicated for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye.

Source page: https://510kreport.com/device/K981640
Methodology: https://510kreport.com/methodology