(122 days)
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The Nd:YAG handpiece is indicated for:
- At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)
The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for:
- Hair Removal
- Permanent hair reduction
- Treatment of vascular lesions
- Treatment of benign pigmented lesions
- Treatment of Leg Veins
- Treatment for pseudofolliculitis barbae
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:
- Hair Removal (650nm filter)
- Permanent hair reduction (650nm filter)
- Treatment of vascular lesions (510nm filter)
- Treatment of benign pigmented lesions (510 nm filter)
- Mild to Moderate inflammatory acne (450nm filter)
The MultiLaser System consists of a console that houses the power supply, control electronics and user interface and four separate handpiece. The four handpieces consist of an Er:YAG laser handpiece, an Nd:YAG laser handpiece, a Diode laser handpiece and an IPL handpiece.
Here's an analysis of the provided 510(k) summary regarding the MultiLaser System, focusing on acceptance criteria and the supporting study information:
Acceptance Criteria and Device Performance Study
The provided document (510(k) summary) explicitly states "Performance Data: None" and "Results of Clinical Study: None". This indicates that no specific acceptance criteria based on performance outcomes or clinical study results are presented, nor is there a study detailing the device's performance against such criteria.
Instead, the submission for the MultiLaser System relies on substantial equivalence to legally marketed predicate devices. The acceptance criteria, in this context, are met by demonstrating that the MultiLaser System's technical specifications and intended uses are sufficiently similar to those of the predicate devices. The "study" proving this is a technical specifications comparison rather than a performance or clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
As no performance data or clinical study results are provided, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in technical specifications to predicate devices. The "reported device performance" in this context refers to the device's technical specifications matching or being within the acceptable range of the predicate devices.
| Specification Category | Acceptance Criteria (Predicate Device) | Reported Device Performance (MultiLaser System) |
|---|---|---|
| Nd:YAG Handpiece | ||
| Energy | Up to 1000mJ (TriPlex K110502) | Up to 1000mJ |
| Maximum Fluence | 12J/cm² (TriPlex K110502) | 12J/cm² |
| Wavelength | 1064nm and 532nm (TriPlex K110502) | 1064nm and 532nm |
| Spot Size | up to 5mm (TriPlex K110502) | up to 5mm |
| Pulse Width | 10ns (TriPlex K110502) | 10ns |
| Pulsewidth (Variable) | Single pulse and variable 0.06 sec - continuous (TriPlex K110502) | Single pulse and variable 0.06 sec - continuous |
| Repetition Rate | 1-5Hz (TriPlex K110502) | 1-5Hz |
| Aiming Beam | HeNe (TriPlex K110502) | HeNe |
| Diode Laser Handpiece | ||
| Light Source | Diode Array (Cheveux K100893) | Diode Array |
| Wavelength | 810nm (Cheveux K100893) | 810nm |
| Energy Density | Up to 100J/cm² (Cheveux K100893) | Up to 100J/cm² |
| Spot Size | 14x 10 mm (Cheveux K100893) | 14x 10 mm |
| Pulse Width | Up to 400ms (Cheveux K100893) | Up to 400ms |
| Beam Delivery System | Light Guide (Cheveux K100893) | Light Guide |
| Er:YAG Laser Handpiece | ||
| Wavelength | 2940nm (TriPlex K110502) | 2940nm |
| Max Power | 2.4 W (TriPlex K110502) | 2.4 W |
| Max Fluence | 8 J/cm² (TriPlex K110502) | 8 J/cm² |
| Pulse Width | 300 μs (TriPlex K110502) | 300 μs |
| Repetition Rate | Up to 10 pulse per second (TriPlex K110502) | Up to 10 pulse per second |
| Spot Size | 1.5mm, 3mm, 6mm, 9mm (TriPlex K110502) | 1.5mm, 3mm, 6mm, 9mm |
| IPL Handpiece | ||
| Light Source | Pulsed Incoherent Light (Apex K110304) | Pulsed Incoherent Light |
| Max Fluence | Up to 35J/cm² (Apex K110304) | Up to 35J/cm² |
| Wavelength | 450 - 1200 nm (Apex K110304) | 450 - 1200 nm |
| Spot Size | 35 x 15 mm² (Apex K110304) | 35 x 15 mm² |
| Pulse Width | Up to 200ms (Apex K110304) | Up to 200ms |
| Beam Delivery System | Light Guide (Apex K110304) | Light Guide |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No test set involving patient data or performance metrics was used for this 510(k) submission. The "test" was a comparison of technical specifications.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth from experts in a clinical or performance setting was not established for this submission. The "ground truth" was the technical specifications of the predicate devices.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical or performance test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. The device is a laser system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. The device is a laser system, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the substantial equivalence determination was the published technical specifications and intended uses of previously cleared predicate devices.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. There was no training set, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.