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510(k) Data Aggregation
(79 days)
PICOALEX
PICOALEX is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma.
The PICOALEX laser system consists of an Alexandrite laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains Alexandrite laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity. To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Alexandrite laser medium, causing the emission of a pulse of laser energy. Power supply and the laser resonator to the laser resonator is calculated from a power supply to the laser energy is set via the LCD monitor is a certain amount of power. In the laser resonator is a certain amount of electrical energy to the flash lamp by changing the electrical energy into light Alexandrite broiling to momentarily strong light in the laser medium to generate a laser. The generated laser is a laser return to convert heat energy reaches thssue is cut by the heat energy, destruction, removal. The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head. The system delivers laser energy at a wavelength of 755 nm. The output of the laser is delivered to the treatment area through an articulated Arm with a handpiece. A trigger (Foot Switch) controls the user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.
The provided text describes a 510(k) submission for the PICOALEX laser system. It does not include information about acceptance criteria for a study proving device performance, nor does it detail such a study.
Instead, it focuses on demonstrating substantial equivalence to a predicate device (Cynosure, LLC's PicoSure Work Station, K210226) based on non-clinical testing and technical characteristics comparison.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device meets acceptance criteria, as this information is not present in the provided document. The document explicitly states:
- "No clinical studies were considered necessary and performed." (Page 9)
The non-clinical tests mentioned are for electrical safety, electromagnetic compatibility, software validation, and biocompatibility, as well as verification of laser performance specifications against established parameters. These are not a "study that proves the device meets the acceptance criteria" in the way you've outlined, which typically implies a clinical or comparative performance study.
**Here's a breakdown of what is available: **
1. A table of acceptance criteria and the reported device performance:
The document presents a comparison to a predicate device, showing that its technical specifications (performance parameters) are either the same or similar, falling within acceptable ranges. These are not "acceptance criteria" in the sense of a performance study with a defined endpoint, but rather design specifications that were verified through bench testing.
| Characteristic | Proposed Device (PICOALEX) | Predicate Device #1 (PicoSure Work Station) | SE Decision (Comment) |
|---|---|---|---|
| Intended Use | For tattoo and benign pigmented lesions removal. | For tattoo and benign pigmented lesions removal, plus acne scars and wrinkles. | Similar, as the intended use of the subject device is included in the intended use of the predicate. |
| Laser Material | Alexandrite | Alexandrite | Same |
| Wavelength | 755nm | 1064nm, 532nm, 755nm | Same (PICOALEX operates at one of the predicate's wavelengths) |
| Laser output power | Max 300mJ ± 20% | Max 300mJ ± 20% | Same |
| Repetition rate | 1-10 Hz | 1-10Hz | Same |
| Pulse width | 600-800ps | 450-900ps | Similar, as the range of the subject device is within that of predicate. |
| Spot size | Zoom: 2-8mm ± 20% | ||
| MLA: 3.5-8mm ± 20% | Zoom: 2-6mm | ||
| Fixed: 6-10mm | Similar. The differences do not raise problem in safety of the device because the larger the spot size, the more the energy of the laser disperse. | ||
| Maximum Average Fluence | 6.37J/cm² | 6.37J/cm² | Same |
Non-Clinical Test Summary (Page 9):
Performance Testing was conducted to define the PICOALEX's parameters:
- Laser wavelength: 755nm
- Laser output power: Max 300mJ ± 20%
- Pulse width: 600-800ps
- Pulse repetition rate: 1-10Hz
The following information is not available in the provided text, as no clinical performance study was conducted:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
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