Anesthesiology
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- Subpart B—Diagnostic DevicesCFR Sub-Part
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- Subpart E—Surgical DevicesCFR Sub-Part
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Light, Lymphedema Reduction, Low Energy
- Page Type
- Product Code
- 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.
- Physical State
- Unit is a hand-held battery powered treatment device, is non-thermal and is used in the contact mode.
- Technical Method
- Device is non-thermal and delivers a controlled series of 200 ns bursts of pulses of 904nm laser beam, which is in the near infrared spectrum that is invisible to the human eye
- Target Area
- Arms of women who have been treated for cancer and have developed post mastectomy lymphedema
- Regulation Medical Specialty
- Physical Medicine
- Review Panel
- General and Plastic Surgery
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 890.5500
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 890.5500 Infrared lamp
§ 890.5500 Infrared lamp.
(a) Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
(b) Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]