(60 days)
The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures.
The MOSAIC 3D Laser System is a non-ablative fractional Er:Glass (Erbium Glass) laser with a wavelength of 1550 nm. It uses Er:Glass to emit a laser beam that is then emitted onto the treatment area via the handpiece connected to the optical fiber of the main body of the system. It is comprised of a main body, a handpiece connected to an optical fiber, a tip, a footswitch, and goggles for laser protection. The laser beam is emitted onto the area to be treated through the tips (roller tip, sapphire tip, comb tip, pill tip) connected to the handpiece.
When the beam contacts tissue the laser beam emits many separate microbeams and creates a microscopic treatment zone (MTZ). Thermal coagulation is then induced in the dermis using the principle of fractional photo thermolysis, sparing the normal skin tissue surrounding the MTZ area. When the laser beam is emitted onto skin tissue, the energy of the beam is absorbed by specific tissues or chromophores such as water and is then converted into thermal energy, causing thermal damage to produce a therapeutic effect.
The MOSAIC 3D Laser System is controlled via a LCD touchscreen guided user interface in the front of the device, which is used to easily configure optimal treatment parameters and check parameters set in the device in the current system mode.
The provided text is a 510(k) summary for the MOSAIC 3D Laser System, a surgical laser. Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of numerical thresholds for accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implied through substantial equivalence to predicate devices and the demonstration of safety and effectiveness through non-clinical and clinical testing.
The primary "performance" being evaluated for this device is its ability to induce coagulation of soft tissue and perform fractional skin resurfacing.
Here’s a table summarizing relevant device characteristics and clinical findings that demonstrate its performance:
| Criterion (Implicit Acceptance) | Reported Device Performance |
|---|---|
| Safety and Essential Performance (Non-Clinical) | Device complies with: |
- IEC 60601-1: 2012, ed 3.1 (Basic Safety and Essential Performance)
- IEC 60601-1-2 Edition 4: 2014 (Electromagnetic Compatibility)
- IEC 60601-2-22: 2012-10 ed 3.1 (Particular Requirements for Laser Equipment)
- IEC 60825-1 Ed. 3.0 (2014) (Safety of Laser Products)
- ISO 10993-5:2009 (Cytotoxicity)
- ISO 10993-10:2021 (Skin sensitization)
- ISO 10993-23:2021 (Skin Irritation) |
| Effectiveness - Coagulation of soft tissue | Histological evaluation showed signs of coagulation formation. (Clinical Study) |
| Effectiveness - Tissue Healing Post-treatment | Histological evaluation showed healing within 4 days after treatment. (Clinical Study) |
| Safety - Adverse Events / Side Effects | All patients experienced mild anticipated side effects (erythema and edema) which typically resolved by end of day. No adverse events were noted during the study duration. (Clinical Study) |
| Substantial Equivalence to Predicate Device (MOSAIC HP K080932) | The MOSAIC 3D shares identical or similar technological characteristics (Laser Type: Er:Glass Fiber laser, Wavelength: 1550 nm, Pulse Energy/MTZ: 4 - 70 mJ, Laser beam spot size: 100um, Cooling Mechanism: Air cooling, Aiming Beam: 658nm
§ 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.