Frax 1940 for Nordlys and Frax Pro

Candela Corporation

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K212492
Device name
Frax 1940 for Nordlys and Frax Pro
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-08-09
Decision date
2021-12-20
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Skin resurfacingPigment treatmentAcne treatmentOther
Primary application
Skin resurfacing
Classification source
AI classified

Indications for 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 (eg Diffuse 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:YAG 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.

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

* 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.

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 (eg Diffuse 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:YAG 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.

Frax Pro system (Ydun) is intended to be used in dermatology, as listed below:
* 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.

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.

Summary parsed at:2026-06-01 05:43:36 UTC

Predicate devices

2

K212492 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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