21 C.F.R. § 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, subject to the limitations in § 878.9.
Notes of Decisions
Cited in 3
cases, 2010–2014 · leading case: PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010).
PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010). “See 21 C.F.R. § 878.4810 (issuing a Class II designation for these types of lasers).”
Bioderm Skin Care, LLC & Quan Nguyen, M.D. v. Veasna \sandee\" Sok", 426 S.W.3d 753 (Tex. 2014). “21 C.F.R. § 878.4810 (b)(1) (categorizing carbon dioxide lasers intended to cut, destroy, or remove tissue as Class II surgical devices).”
Rio Grande Valley Vein Clinic, P.A., D/B/A Rgv Vein Laser & Aesthetic Clinic v. Yvette Guerrero, 431 S.W.3d 64 (Tex. 2014). “The United States Food and Drug Administration classifies the pulsed dye laser used for Guerrero’s treatment as a Class II surgical device, 21 C.F.R. § 878.4810 (b)(1), the use of which federal regulations specify is “not safe except under the supervision of a practitioner…”
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