(114 days)
The IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
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.
The proposed device, IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy)is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
IPL are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 480mm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
Diode Laser machine is based on the principles of selective photothermolysis (SPTL): a combination of the appropriate laser wavelength, pulse duration, and fluence can obtain optimal effect on a targeted tissue with minimal effect on surrounding tissue.
Wavelengths of 808 nanometers (nm) are widely used in hair removal treatment, it is selectively absorbed by melanin in the hair shaft, damaging the follicular epithelium, and further causes hair loss, while the competing chromophores (oxyhemoglobin and water) absorb less energy at these wavelengths.
The user could power on the device and use the key switch to start the system, and then set the output parameter, when the setting is done, the user could use the handpiece to aim the area to be treated by 808 nm laser delivering , the laser emitting could be triggered by foot switch controlled by user.
Function module description: Control Panel, Main Control Module, Constant current board module, Temperature and humidity control system, Handpiece module.
This document is a 510(k) Summary for a medical device (IPL + Diode Laser Machine) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel AI/software medical device.
Therefore, most of the requested information for an AI/software medical device (like acceptance criteria for AI performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable to this document.
However, I can extract information related to the device's non-clinical performance and the demonstration of its safety and effectiveness relative to predicates.
Here's what can be extracted and what cannot be for this specific document:
Information that CANNOT be extracted from this document (due to the nature of the device and submission type):
- A table of acceptance criteria and the reported device performance (for AI/software performance metrics): This document does not describe acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC) or report those metrics. It focuses on the device's physical and functional specifications.
- Sample sized used for the test set and the data provenance: No test set in the context of AI/software performance is mentioned. The "tests" refer to compliance with electrical, laser, and biocompatibility standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted reading device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for AI performance ground truth.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Information that CAN be extracted regarding the device's non-clinical performance and comparison to predicates:
1. A table of acceptance criteria and the reported device performance
(Note: These are non-clinical hardware/physical criteria, not AI performance metrics)
| Acceptance Criteria (Predicate Device Values) | Reported Device Performance (Proposed Device) | Remark/Comparison Outcome |
|---|---|---|
| IPL Performance | ||
| Energy density: 1-50 J/cm² | 1-40 J/cm² | Analysis 1 (Different, but guaranteed by standards compliance) |
| Max. Power: 2200W | 2200 VA | SE (Substantially Equivalent) |
| Wavelength (hair reduction): 640-1200 nm | 640-1200 nm | SE |
| Energy Range (hair reduction): 10-44 J/cm² | 11-40 J/cm² | Analysis 1 (Different, but guaranteed by standards compliance) |
| Pulse Width (hair reduction): 3-14 ms | 16-32 ms | Analysis 1 (Different, but guaranteed by standards compliance) |
| Pulse Delay (hair reduction): 16-32 ms | 5-14 ms | Analysis 1 (Different, but guaranteed by standards compliance) |
| Spot Size (hair reduction): 12*30 mm² | 15*50 mm² | Analysis 1 (Different, but guaranteed by standards compliance) |
| Wavelength (pigmented lesions): 480-1200 nm | 480-1200 nm | SE |
| Energy Range (pigmented lesions): 12-44 J/cm² | 10-40 J/cm² | Analysis 1 (Different, but guaranteed by standards compliance) |
| Pulse Width (pigmented lesions): 3-9 ms | 16-32 ms | Analysis 1 (Different, but guaranteed by standards compliance) |
| Pulse Delay (pigmented lesions): 16-32 ms | 3-8 ms | Analysis 1 (Different, but guaranteed by standards compliance) |
| Spot Size (pigmented lesions): 12*30 mm² | 15*50 mm² | Analysis 1 (Different, but guaranteed by standards compliance) |
| Wavelength (vascular lesions): 590-1200 nm | 590-1200 nm | SE |
| Energy Range (vascular lesions): 10-42 J/cm² | 10-40 J/cm² | Analysis 1 (Different, but guaranteed by standards compliance) |
| Pulse Width (vascular lesions): 3-8 ms | 16-32 ms | Analysis 1 (Different, but guaranteed by standards compliance) |
| Pulse Delay (vascular lesions): 16-32 ms | 5-9 ms | Analysis 1 (Different, but guaranteed by standards compliance) |
| Spot Size (vascular lesions): 12*30 mm² | 15*50 mm² | Analysis 1 (Different, but guaranteed by standards compliance) |
| Diode Laser Performance | ||
| Laser Type: Diode Laser | Diode Laser | SE |
| Laser Classification: Class IV | Class IV | SE |
| Laser Wavelength: 808 nm | 808 nm | SE |
| Spot Size: 1.2 cm² | 13*13mm² (1.69 cm²) | Analysis 2 (Different, but guaranteed by standards compliance) |
| Fluence: 1-70 J/cm² | 1-69 J/cm² | Analysis 2 (Different, but guaranteed by standards compliance) |
| Frequency: 1-20 Hz | SHR: 1-10 Hz, LHR: 1-3 Hz | Analysis 2 (Different, but guaranteed by standards compliance) |
| Pulse Duration: 5-400 ms | 5-400 ms | SE |
| Safety & Biocompatibility | ||
| Cytotoxicity: No Cytotoxicity | No Cytotoxicity | SE |
| Sensitization: No evidence of sensitization | No evidence of sensitization | SE |
| Irritation: No evidence of irritation | No evidence of irritation | SE |
| Electrical Safety: Comply with IEC 60601-1, IEC 60601-2-22, IEC60601-2-57 (overall for both IPL & Diode Laser) | Comply with IEC 60601-1, IEC 60601-2-22, IEC60601-2-57 | SE |
| EMC: Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety: Comply with IEC 60601-2-22, IEC 60825 (overall for both) | Comply with IEC 60601-2-22, IEC 60825, IEC60601-2-57 | SE |
| Power Supply: AC 110V 50Hz / AC 110V/60Hz or 250V 50Hz | AC110V, 50/60Hz | SE |
| Dimension (Predicate 1): 430x 590 x 1360 mm, (Predicate 2): 598x440x1093mm | 620x610x1290mm | Analysis 3 (Different, but determined not to affect safety/effectiveness) |
| Weight (Predicate 1): 45kg, (Predicate 2): 60Kg | 78kg | Analysis 3 (Different, but determined not to affect safety/effectiveness) |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The "tests" mentioned are for compliance with recognized electrical, laser, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993 series). These tests are typically performed on the device itself and its components, not on a "test set" of patient data for AI performance evaluation.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is cleared based on substantial equivalence to existing devices, relying on non-clinical engineering and safety standards, not on AI performance requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- No MRMC study was done (or required) as this is not an AI-assisted reading device. The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical IPL+Laser machine, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the purpose of this 510(k), the "ground truth" for demonstrating substantial equivalence is the existing predicate devices and compliance with recognized international standards for medical electrical equipment, laser products, and biocompatibility. There is no patient-data-driven ground truth in the context of AI performance for this submission.
8. The sample size for the training set:
- Not applicable. This device does not use an AI training set.
9. How the ground truth for the training set was established:
- 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.