LogoFDA 510(k) Search
K Number
K212492
Device Name
Frax 1940 for Nordlys and Frax Pro
Manufacturer
Candela Corporation
Date Cleared
2021-12-20

(133 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K192951,K130193
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Nordlys system is intended to be used in dermatology as listed below:

Nordlys System + Intense pulse light applicators:

  • Permanent Hair Reduction (defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen) (overall 600 - 950 nm).
  • Treatment of Telangiectasias (530-750 nm or 555-950 nm)
  • Treatment of Port Wine Stains (530-750 nm or 555-950 nm)
  • Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation. Ephelides) and Benign Vascular Lesions (ex Diffiuse Redness) (530-750 nm or 555-950 nm)
  • Treatment of Rosacea (530-750 nm or 555-950 nm)
  • Treatment of Poikiloderma of Civatte (530-750 nm or 555-950 nm)
  • Treatment of Benign Epidermal Pigmented Lesions (eg Solar Lentigines ) (400-720 nm)
  • Treatment of Inflammatory Acne Vulgaris (530-750 nm)

Nordlys System + Nd: Y AG Laser (1064 nm):
*Treatment of Leg Vessels (0.1-3.0 mm diameter).

  • Treatment of Benign Vascular Lesions.
  • Treatment of Venous Lakes.
  • Treatment of Port Wine Stains.
  • Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
  • Treatment of benign cutaneous lesions, such as warts.
    Podiatry (ablation, vaporization, incision, and coagulation of soft tissue), including:
  • Matrixectomy
  • Periungal and subungal warts
  • Plantar warts.

Nordlys System + Frax 1940 Laser (1940 nm):

  • The Frax 1940 is indicated for use in dermatological procedures requiring the coagulation of soft tissue and for skin resurfacing procedures.
    Frax 1940 is indicated for treatment of benign pigmented lesions, such as but not limited to lentigines (age spots), solar lentigines (sunspots), and ephelides (freckles) for Fitzpatrick Skin Types I-IV.

Nordlys System + Frax 1550 Laser (1550 nm):

  • The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Frax Pro system (Y dun) is intended to be used in dermatology, as listed below:

Frax Pro System + Frax 1940 (1940 nm)
*The Frax 1940nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
Frax 1940 is indicated for treatment of benign pigmented lesions, such as but not limited to lentigines (age spots), solar lentigines (sunspots), and ephelides (freckles) for Fitzpatrick Skin Types I-IV.

Frax Pro System + Frax 1550 (1550 nm)
*The Frax 1550nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Device Description

The Frax 1940 applicator is used with the Nordlys and Frax Pro system (previous called Ydun).

The Nordlys and Frax Pro systems consist of a console containing power unit and control electronics with control and display panel, including software. The Frax 1940 applicator connects to the systems and has built in Laser diodes emitting 1940 nm light in a fractional pattern.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called "Frax 1940 for Nordlys and Frax Pro Systems." This device is a laser system intended for dermatological procedures.

However, the provided document DOES NOT contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it does not include:

  1. A table of acceptance criteria and reported device performance: This document only states that "results of the clinical studies demonstrated favorable safety and effectiveness profile," but no specific metrics or comparison to acceptance criteria are provided.
  2. Sample sizes used for the test set and data provenance: No details about the number of subjects in the clinical studies, their demographics, or where the data was collected are given.
  3. Number of experts used to establish ground truth and qualifications: The document mentions "clinical studies" but not how ground truth was established, or the qualifications of any experts involved in that process.
  4. Adjudication method for the test set: Not mentioned.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: This is not a study type relevant to this type of laser device (which treats skin directly) and is typically used for diagnostic or imaging AI.
  6. Standalone (algorithm only) performance: Not applicable as this is a physical laser device, not an AI algorithm.
  7. Type of ground truth used: Not specified, beyond "effectiveness profile" for "benign pigmented lesions removal."
  8. Sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set in the typical sense. The "clinical studies" mentioned are for validation/testing, not training.
  9. How the ground truth for the training set was established: Not applicable.

What the document does state about "performance data" (Section 9):

  • Performance Standards: The device has been tested according to and complies with several IEC and EN standards related to medical electrical equipment and laser safety:
    • IEC 60601-1 (General requirements for basic safety and essential performance)
    • IEC 60601-1-2 (Electromagnetic Disturbances)
    • EN 60825-1 (Safety of laser products Equipment classification and requirements)
    • IEC 60601-2-22 (Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment)
  • Clinical Testing: "Two clinical studies were conducted on the Frax 1940 to support the new indications of benign pigmented lesions."
  • Clinical Study Results: "The results of the clinical studies demonstrated favorable safety and effectiveness profile for the Frax 1940 nm laser system for the indicated use for benign pigmented lesions removal after 1-3 treatment sessions."

In summary, this document confirms that clinical studies were performed to demonstrate safety and effectiveness for the stated indications. However, it does not provide the detailed methodology or quantitative results of these studies, which would be necessary to answer the specific questions about acceptance criteria and how they were met.

To provide the information you requested, you would typically need access to the full 510(k) submission, specifically the sections detailing the clinical study protocols and results, which are often redacted or not publicly available in the FDA 510(k) summary.

§ 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.