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K Number
K213056
Device Name
LED Facial Mask
Manufacturer
Shenzhen OSTO Technology Company Limited
Date Cleared
2022-07-07

(288 days)

Product Code
OLP,OHS
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

LED Facial Mask is an over the counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The Red and Infrared light combination mode is intented for the treatment of full-face wrinkles. The blue light is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.

Device Description

LED Facial Mask (Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B)

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for an LED Facial Mask. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The letter only states that the device is "substantially equivalent" to a legally marketed predicate device for the following indications for use:

  • Red light mode: Treatment of periorbital wrinkles.
  • Red and Infrared light combination mode: Treatment of full-face wrinkles.
  • Blue light: Treatment of mild to moderate inflammatory acne.
  • Target population: Adults only.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, not in the 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.