LogoFDA 510(k) Search
K Number
K020513
Device Name
EPY-50
Manufacturer
DDC TECHNOLOGIES, INC.
Date Cleared
2002-05-16

(90 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. The EPY-50 PULSED Nd: YAG LASER is intended to effect TEMPORARY HAIR REDUCTION in skin types I-IV.
  2. The EPY-50 PULSED Nd: YAG LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
  3. VASCULAR LESIONS.
Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the EPY-50 PULSED Nd:YAG LASER. It does not contain the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for proving the device meets acceptance criteria.

The letter primarily:

  • Confirms that the device is substantially equivalent to legally marketed predicate devices.
  • Lists the indications for use for the device.
  • Outlines general regulatory requirements.

Therefore, I cannot provide the requested table and study details based on the input document.

§ 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.