Last synced on 12 July 2024 at 11:04 pm

Over The Counter Thermal Treatment For Acne.

Page Type
Product Code
Definition
For the treatment of mild to moderate inflammatory acne.
Physical State
In addition to the device, there may be batteries, re-charger, USB cable
Technical Method
Deliver heat to acne to kill propionibacterium acne virus
Target Area
Acne/pimples
Regulation Medical Specialty
Physical Medicine
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.5740
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 890.5740 Powered heating pad

§ 890.5740 Powered heating pad.

(a) Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]

Over The Counter Thermal Treatment For Acne.

Page Type
Product Code
Definition
For the treatment of mild to moderate inflammatory acne.
Physical State
In addition to the device, there may be batteries, re-charger, USB cable
Technical Method
Deliver heat to acne to kill propionibacterium acne virus
Target Area
Acne/pimples
Regulation Medical Specialty
Physical Medicine
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.5740
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 890.5740 Powered heating pad

§ 890.5740 Powered heating pad.

(a) Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]