Light, Lymphedema Reduction, Low Energy

NZY · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5500

Classification

FDA Product Code: NZY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.5500
Review panel: SU
Medical specialty: Physical Medicine
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown