(231 days)
The DEKA Synchro Repla:Y family of laser systems is indicated for:
755mn laser:
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) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
l 064nm laser:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation 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 of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for 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.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
Pulsed light FT handpiece:
Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table: -
| Pulsed light
| wavelength range | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions |
|---|---|---|---|---|
| 500 - 1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520 - 1200nm | - | Skin Type III | Skin Type III | Skin Types I, II |
| 550 - 1200nm | Skin Types I, II | - | - | Skin Type III |
| 600 - 1200nm | Skin Type III | - | - | - |
| 650 - 1200nm | Skin Type IV | - | - | Skin Type IV |
The Deka Synchro Repla: Y family of lasers is a platform which can be equipped with two separate solid state laser heads (755nm and 1064nm) and a pulsed light handpiece (FT handpiece).
The two laser heads can only be activated separately and they deliver the laser output through the same single laser delivery system, consisting of a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
The FT handpiece delivers the pulsed light to the treatment area by means of a sapphire lightguide: it is provided with has an integrated skin cooling system and is equipped with five different emission spectra interchangeable filters.
The system allows to switch from one of the three available sources to the other by pressing a key on touch panel.
Handpiece activation is either by footswitch or fingerswitch.
This document is a 510(k) summary for a medical laser system and does not contain information about acceptance criteria or a study proving its performance in the context of an AI/algorithm-based device as typically presented in such studies. The device is a physical laser system, not an AI or software algorithm that provides diagnostics or interpretations.
The document discusses "Clinical Performance Data: None" and "Non-Clinical Performance Data: Performance data has been provided in order to show that the Deka Synchro Repla: Y Software complies with the Requirements of the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' issued by the FDA on May 11, 2005. Moreover, performance data has been provided in order to show that the Deka Synchro Repla: Y complies with the EMC requirements of the FDA Recognized Standard IEC 60601-1-2 and with the FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities."
This statement indicates that the software performance data is primarily about compliance with regulatory guidance for medical device software and EMC standards, not about clinical effectiveness as you would expect for an AI algorithm making diagnostic predictions.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert ground truth, or AI performance metrics because this information is not present in the provided text for this type of device. The provided text is a 510(k) summary for a physical medical laser device establishing substantial equivalence to predicate devices based on technical specifications and intended use, not clinical performance data for an AI-powered diagnostic or assistive tool.
§ 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.