(32 days)
The FoLix System, with wavelength of 1565 mm. is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.
The FoLix™ is a laser system intended to be used for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The FoLix™ laser system with a wavelength of 1565 nm and consists of the following:
- The laser console includes a power supply unit, a Laser module (+ aiming beam), a control ● unit and a PC module. The laser beam is transferred to the handpiece via fiber optics.
- The handpiece includes a scanner module built of two mirrors that are controlled by two ● motors directing the Laser beam to desired target tissue.
- The handpiece uses a tip to align the Laser beam focus with the target tissue, enabling a . treatment shape size and a thermo-electric cooler (TEC).
The FoLix™ is intended for professional use only.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the FoLix System, which is a laser system intended for improving the appearance of scalp hair.
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (F65 Laser System, K222790). This means the manufacturer is asserting that the new device is as safe and effective as the predicate device, not necessarily that it meets specific, independently established performance criteria through a new clinical study.
Here's what the document does state regarding validation:
- Summary of Bench Verification: This includes risk analysis (ISO 14971), electrical, laser, and electromagnetic compatibility safety testing (IEC 60601-1 and IEC 60601-1-2), software verification and validation (IEC 62304 and FDA Guidance "Principles of Software Validation"), system testing, and usability assessment (FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices", IEC 62366-1 and IEC 60601-1-6). These are standard engineering and safety tests, not clinical performance acceptance criteria.
- Summary of Clinical Validation: It explicitly states, "No new clinical validation was required to support the FoLix as the clinical validation of the Lumenis predicate device also applies to the subject device." This indicates that any clinical performance claims are based on the predicate device's data, not a new study for the FoLix system with specific acceptance criteria.
Therefore, I cannot provide the requested table or details about a study proving the device meets acceptance criteria because:
- No Acceptance Criteria are Quantitatively Defined: The document does not list specific, measurable acceptance criteria for device performance (e.g., a certain percentage improvement in hair appearance, specific accuracy/sensitivity/specificity metrics).
- No New Performance Study Presented: The document explicitly states that no new clinical validation was required. It relies on the clinical validation of its predicate device, of which no details are provided in this text.
To answer your request, information regarding the predicate device's clinical validation, including its acceptance criteria and study details, would be necessary. This document focuses on demonstrating that the FoLix system is substantially equivalent to that predicate, given its modifications (removal of handpieces, minor hardware/software changes).
§ 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.