# K935459: Omron Massager Model HM-45

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Mar 4, 1994 after 112 days
- Product code: ISA (Massager, Therapeutic, Electric)
- Device class: 1
- Regulation: 21 CFR 890.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
403 later devices descend from it; 1 cites it directly.
0 of 404 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K042630: Revlight Skin Care System (2005), 402 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K060792: Illumimed (2006), 115 descendants of its own

Source page: https://510kreport.com/device/K935459
Methodology: https://510kreport.com/methodology