FDA regulation numbers

FDA regulation numbers

FDA classifies all devices under regulation numbers and corresponding three-letter product codes. Hair removal devices are classified in the Federal Register under the three regulation numbers below.

Note the difference in wording between intended uses for needle-type and tweezer-type epilators, marked in orange.

Docket 97N-0199 changed the wording of electric tweezer device identification because there is "no published scientific data demonstrating that the device permanently destroys hair."

878.5350 Needle-type epilator.

(a) Identification. A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996.]

878.5360 Tweezer-type epilator.

(a) Identification. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the
tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.
[63 FR 57060, Oct. 26, 1998]

878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a) Identification.

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

(b) Classification.

(1) Class II.

(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996]

 

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