(266 days)
EPILDREAM HP 4000 MED is indicated for: use in aesthetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.
760 nm wavelength laser is indicated for : Hair removal, permanent hair reduction*
808 nm wavelength laser is indicated for : Hair removal, permanent hair reduction*
1060 nm wavelength laser is indicated for:
- · Treatment of pseudofolliculitis barbae (PFB)
- · Hair removal, permanent hair reduction*
*Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The handpiece which uses three wavelengths simultaneously is indicated for use in dermatology procedures requiring coagulation, and for the removal of benign vascular and vascular dependent lesions.
Not Found
The provided text is a 510(k) summary for the EPILDREAM HP 4000 MED device. It outlines the regulatory clearance and indications for use. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to legally marketed predicate devices, not on detailed performance study results.
§ 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.