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K Number
K061470
Device Name
DEL SOL BLUE LIGHT THERAPY SYSTEM
Manufacturer
EDGE SYSTEMS CORPORATION
Date Cleared
2006-07-20

(55 days)

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

The Del Sol Blue Light Therapy System is intended to provide photo therapeutic light to the body. The Del Sol Blue Light Therapy System is generally indicated to treat dermatological conditions. The Del Sol Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.

Device Description

Not Found

AI/ML Overview

I am unable to answer your request. The provided text is a 510(k) clearance letter from the FDA for a medical device (Del Sol Blue Light Therapy system).

While this letter confirms that the device is cleared for market based on substantial equivalence to a predicate device, it does not contain the detailed study information, acceptance criteria, or performance data that you are requesting. Such information would typically be found in the actual 510(k) submission document or a summary thereof, which is not provided in the given text.

Therefore, I cannot extract the following information from the provided text:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, number of experts, adjudication methods for test sets.
  • Information on MRMC studies or standalone algorithm performance.
  • Details about the ground truth used or how it was established for training and test sets.
  • Sample size for the training set.

§ 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.