Last synced on 30 September 2022 at 11:05 pm

Laser, Comb, Hair

Page Type
Product Code
Definition
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Physical State
Light emitting stimulator
Technical Method
Pass laser light emitting comb across the scalp three times a week for at least 26 weeks.
Target Area
Growth of scalp hairs
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]

Laser, Comb, Hair

Page Type
Product Code
Definition
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Physical State
Light emitting stimulator
Technical Method
Pass laser light emitting comb across the scalp three times a week for at least 26 weeks.
Target Area
Growth of scalp hairs
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]