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K Number
K170734
Device Name
Venus Silk.expert
Manufacturer
Cyden Limited
Date Cleared
2017-05-08

(59 days)

Product Code
GEX,DAT,OHT
Regulation Number
878.4810
Type
Special
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Venus Silk.expert Hair Removal System is indicated for the removal of unwanted hair. The Venus Silk.expert is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter (K170734 for Venus Silk.expert) does NOT contain any information about acceptance criteria, the study that proves the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a standard FDA clearance letter confirming substantial equivalence to a predicate device for the Venus Silk.expert Hair Removal System. It details:

  • The device name and regulation numbers.
  • The indications for use (removal of unwanted hair, permanent reduction in hair regrowth).
  • That it is cleared for Over-The-Counter Use.
  • General FDA compliance information.

To answer your request, you would need different documentation, such as the full 510(k) submission, clinical study reports, or performance testing data, which are not included in this FDA clearance letter.

§ 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.