(104 days)
The APL MEDICAL SYSTEM is a modular multi-laser and multi-use device and are intended for use in aesthetic, cosmetic, and surgical applications.
It is used to treat common imperfections and lesions of skin and body , including:
-
- The removal of unwanted hair and to effect stable long-term or permanent hair reduction
-
- Laser skin treatment procedures for the treatment of:
- Acne scars .
- Wrinkles .
-
- Incision, excision, ablation, vaporization of soft tissue
- The non-ablative treatment of facial wrinkles, such as, but not limited to: 4.
- Periocular wrinkles .
- . Perioral wrinkles
-
- Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
-
- Treatment of capillaries, teleangiectasies and vascular lesions
-
- Treatment of vitiligo and psoriasis
The portable device APL MEDICAL SYSTEM, is a multi-laser and pulsed light system, designated to act on the most diffused imperfections of the skin and body. The equipmentm is conceived as an expandable system for the field of aesthetic medicine, composed of a modular platform, containing the entire electronics of the system and the cooling circuit, and a series of interchangeable hand pieces to be connected on the platform, finalized to treat specific groups of imperfections. A rapid connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform. The following hand pieces are available:
- Hand piece Pulsed Light. With the use of this hand piece the removal of unwanted hair is extremely quick and efficient, as it is possible to treat large areas (up to 9 cm2) using a single pulse or "burst" mode This system is effective on varius skin types. On this hand piece it is possible to change easily the guide light, equipped with a specific light filter and to use thus that one most adequate for the individual photo type. Furthermore, it is possible to conduct a combination of methods to attenuate facial skin imperfections related to small perorbital and labial wrinkles. With the use of guide lights within the spectrum 300-380 nm it is possible to treat psoriasis and vitiligo disease with a specific therapy. This technique has the advantage of acting directly on the concerned area while respecting the surrounding tissues.
- Hand piece Nd:Yag Laser at 1064nm, long pulse (ms). With this laser it is possible to treat teleangectasies easyly and quickly with optimal results and without leaving a cicatrix. Furthermore, it is possible to hair removal on small areas with "difficult" skin and hairs.
- Hand piece Nd: Yag Laser 1064 and 532 nm Qs (Qswitched), short pulse (ns). This laser is able to selectively destroy melanosomes through cell lysis. The Qs laser is ideal for the treatment of pigmentated lesions and in general for all superficial pigmentations, since its wavelength is well absorbed by the melanin as well as by the haemoglobin. Furthermore, the pulse width makes this type of laser selective with regards to melanosomes -i.e. benign freckles, ephelis, café-au-lait stains, nervus pilus, seborrheic keratosis and skin chloasm, and tattoos. Fin and superficial vessels are better treated with the Nd: Yag laser 532 nm Qs which causes less pain than other laser types, completing the treatment which may effect the Nd:Yag laser, long pulse.
- Hand piece Erbium Laser at 2.940 nm. Due to the high power and the exclusive guide light, the use of this laser results in the ablation process which is a delicate and uniform exfoliation of the atrophic superficial (5 micron) layer of the skin.
The provided 510(k) summary for the APL MEDICAL SYSTEM does not include any acceptance criteria or a study proving the device meets said criteria.
Instead, the submission relies solely on a demonstration of substantial equivalence to a previously marketed predicate device (MSq(M2) LTD - Lovely System, K042000 and K033946). This type of submission, common for 510(k) clearances, posits that because the new device is sufficiently similar to an already cleared device in terms of design, intended use, and performance characteristics, it is therefore as safe and effective.
Here's a breakdown of why the requested information about acceptance criteria and studies is not present in this document:
- No Acceptance Criteria: The document does not define specific performance metrics or thresholds for the APL MEDICAL SYSTEM to achieve.
- No Studies Demonstrating Performance Against Acceptance Criteria: Since no acceptance criteria are defined, no study is presented to show the device meets them. The document explicitly states:
- "Non-Clinical Performance Data: None"
- "Clinical Performance Data: None"
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this information is not provided in a submission based purely on substantial equivalence without performance data.
Summary of what is available from the document regarding the substantial equivalence argument:
| Information Sought | Response (Based on Provided Text) |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not Applicable: The document does not provide acceptance criteria or performance data for the APL MEDICAL SYSTEM. Its clearance is based on substantial equivalence to a predicate device. |
| 2. Sample size used for the test set and the data provenance | Not Applicable: No test set was used for performance evaluation as no clinical or non-clinical performance data was submitted. The submission relies on demonstrating similarity to a predicate device. |
| 3. Number of experts used to establish the ground truth for the test set and their qualifications | Not Applicable: No test set with ground truth established by experts was used. |
| 4. Adjudication method for the test set | Not Applicable: No test set requiring adjudication was used. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size | Not Applicable: No MRMC comparative effectiveness study was performed. |
| 6. If a standalone (algorithm only) performance study was done | Not Applicable: The APL MEDICAL SYSTEM is a physical laser system, not an algorithm. No standalone performance study was reported. |
| 7. The type of ground truth used | Not Applicable: No ground truth was established as no performance studies were submitted. |
| 8. The sample size for the training set | Not Applicable: This is a physical device, not an AI/ML algorithm that requires a training set. |
| 9. How the ground truth for the training set was established | Not Applicable: This is a physical device, not an AI/ML algorithm that requires a training set and associated ground truth. |
§ 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.