Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)— 510(k) K153389
Substantially EquivalentIn Light Wellness Systems, Inc.
FDA 510(k) clearance K153389 for Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom), Substantially Equivalent on 2016-03-30. Applicant: In Light Wellness Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- In Light Wellness Systems, Inc.
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Albuquerque, NM, US
Recent devices under product code ILY
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- K221189 — OLIZ LTB-1000A
Adverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K153389
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153389.
Data sourced from openFDA. This site is unofficial and independent of the FDA.