← FDA Medical Device Classifications

Lamp, Infrared, Therapeutic Heating

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

Classification

FDA Product Code

ILY

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 890.5500

Review panel

PM

Medical specialty

Physical Medicine

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

229

Registered establishments

435

Source

Authoritative

FDA Device Classification database

Machine

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