Syneron EPLUS SKIN TREATMENT SYSTEM

Posting of FDA 510(k) Approval Documents that are part of the public record on the FDA's Website. You can go to this link and review 510(k) appoval summaries for all medical devices going back to 1999:

http://www.fda.gov/MedicalDevices/Produ ... 242632.htm

Syneron EPLUS SKIN TREATMENT SYSTEM

PostPosted by DCNGA » Fri Jun 22, 2012 5:09 pm

510(k) Approval:

http://www.accessdata.fda.gov/scripts/c ... m?ID=38730

Regulation:

Sec. 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.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]
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