510(k) Report

FDA applicant

In Light Wellness Systems, Inc.

Albuquerque, NM1 decision2016–20161 recall

FDA records 1 decision for In Light Wellness Systems, Inc. (Albuquerque, NM) in 2016: 1 510(k) clearance. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided In Light Wellness Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2016high 1 (2019) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — In Light Wellness Systems, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ILYLamp, Infrared, Therapeutic Heating1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K153389Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)In Light Wellness Systems, Inc. · 20161 recall

The one decision as In Light Wellness Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K153389inLight Medical LED Pads used with Polychromatic light technology systemJun 4, 2019Class III