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510(k) Data Aggregation
K Number
K233090Device Name
DEKA AGAIN PRO family
Manufacturer
El. En. S.p.A.
Date Cleared
2023-10-27
(31 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
El. En. S.p.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEKA AGAIN PRO family is a medical laser family intended for:
Alexandrite laser (755nm):
- Temporary hair reduction.
- Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles.
- Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the completion of a treatment regime on all skin types (Fitzpatrick I-VI) included tanned skin.
- Treatment of benign pigmented lesions.
- Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG laser (1064nm):
- Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzapatrick I-VI including tanned skin.
- Photocoaqulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
- Coagulation and hemostasis od soft tissue.
- Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
- Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Treatment of wrinkles.
Device Description
The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser.
The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wider range of interchangeable, quick release laser handpieces with electronic spot recognition.
The modifications to the device consist in a restyling of the device (new chassis, cover plastic, dimensions, weight and GUI, removal of Pulsed Light FT handpiece) and in modification to spot size ranges (new spot size available).
The intended use of the modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.
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