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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

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]

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

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]