(116 days)
The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in hair removal, moderate inflammatory acne vulgaris, and benign cutaneous vascular lesions.
The Multifunctional Series device are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 530nm-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. Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penctration without using excessive energy levels and enables targeting of specific chromophores. Based on this, The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic applications in hair removal, acne, and blood vessel lesions. The proposed device includes four models as Aeslight-S3D, HONKON-S3C. HONKON-M40e+ and HONKON-M80e+.
The provided 510(k) summary (K131859) describes a Substantial Equivalence (SE) determination for the Multifunctional Series IPL device. This type of submission relies on comparing the new device to existing legally marketed predicate devices rather than conducting new clinical studies to prove efficacy and safety from scratch.
Here's an analysis of the provided information concerning acceptance criteria and supporting evidence:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. This means that the proposed device must be as safe and effective as the predicate device(s) and have similar technological characteristics and intended use. The "acceptance criteria" are therefore represented by the characteristics of the predicate devices. The "reported device performance" is the specification of the proposed device, which is considered acceptable if it falls within a similar range or has slight differences that do not affect safety or effectiveness.
Below is a combined table summarizing the key performance parameters of the proposed device (Multifunctional Series) and its two primary predicate devices (Intense Pulsed Light (IPL) Systems (K122995) and IPULSELIGHT IPL SYSTEM (K093627)). The "Remark" column indicates if the characteristic is considered "Substantially Equivalent" (SE) or subject to "Analysis," which then details why the difference is deemed acceptable.
Table 1: Multifunctional Series Device Performance vs. Predicate Devices
| ITEM | Proposed Device (Multifunctional Series) | Predicate Device 1 (K122995) | Predicate Device 2 (K093627) | Acceptance Criteria (based on Predicate Range) | Reported Device Performance (Proposed Device) | Acceptance Met? (Based on document's analysis) |
|---|---|---|---|---|---|---|
| General Characteristics | ||||||
| Light Source | Intense pulsed light | Intense pulsed light | Intense pulsed light | Intense pulsed light | Intense pulsed light | Yes (SE) |
| Deliver system | Sapphire | Sapphire | Sapphire | Sapphire | Sapphire | Yes (SE) |
| Max. Power (W) | 2000 W (Aeslight-S3D, HONKON-S3C), 1250 W (HONKON-M40e+, HONKON-M80e+) | 2000 W | 1200 W | 1200 - 2000 W | 1250 W - 2000 W | Yes (Analysis 7) |
| Operating Parameters | ||||||
| Wavelength (nm) | 610-1200nm, 585-1200nm, 530-1200nm (depending on application) | 430-1200nm, 530-1200nm, 640-1200nm (Optional: 480-1200nm, 560-1200nm, 590-1200nm, 690-1200nm, 750-1200nm) | 420nm-1200, 510-1200nm, 560-1200nm, 610-1200nm, 640-1200nm (Standard); 480nm-1200, 585-1200nm, 690-1200nm, 755-1200nm (Options) | Overlapping ranges with predicates (e.g., 530-1200nm, 585-1200nm, 610-1200nm) | Within or very close to predicate ranges | Yes (Analysis 1) |
| Energy Range (J/cm²) | 20-50 J/cm² | 10-60 J/cm² | 10-60 J/cm² | 10-60 J/cm² | 20-50 J/cm² | Yes (Analysis 2) |
| Pulse Delay (ms) | 0.1-40 ms | 5 - 50 ms | 5 - 50 ms | 5 - 50 ms | 0.1-40 ms | Yes (Analysis 3) |
| Pulse Duration (ms) | 1-25 ms | 1-20 ms | 2-20 ms | 1-20 ms (Predicate 1), 2-20 ms (Predicate 2) | 1-25 ms (Proposed device covers and slightly exceeds upper bound of predicates, but deemed acceptable) | Yes (Analysis 4) |
| Spot size | 8mm40mm, 15mm60mm | MED-210: 15mmX50mm (optional: 12mmX33mm, 15mmX35mm); MED-230: A: 12mm X33mm; B: 15mmX50mm (optional: 15mmX35mm) | 12x35mm, 15x50mm (Standard); 12x12mm, 12x25mm, 12x50mm, 15x35mm, 15x45mm (Options) | Various similar sizes offered by predicates (e.g., 12x33mm, 15x50mm, 12x35mm, 15x45mm) | 8mm40mm, 15mm60mm | Yes (Analysis 5) |
| Specific IFU Settings | ||||||
| Hair Removal Wavelength | 610-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Overlapping/similar ranges. | 610-1200 | Yes (Analysis 6) |
| Hair Removal Energy | 20-50 | 10-44 | 10-46 | Overlapping/similar ranges. | 20-50 | Yes (Analysis 6) |
| Hair Removal Pulse Duration | 3-15 ms | 3-14 | 4-15 | Overlapping/similar ranges. | 3-15 ms | Yes (Analysis 6) |
| Hair Removal Pulse Delay | 15-35 | 16-32 | 15-30 | Overlapping/similar ranges. | 15-35 | Yes (Analysis 6) |
| Acne Wavelength | 530-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Overlapping/similar ranges. | 530-1200 | Yes (Analysis 6) |
| Acne Energy | 20-50 | 10-40 | 10-42 | Overlapping/similar ranges. | 20-50 | Yes (Analysis 6) |
| Acne Pulse Duration | 3-10 | 3-8 | 3-9 | Overlapping/similar ranges. | 3-10 | Yes (Analysis 6) |
| Vascular Lesions Wavelength | 585-1200 | 640-1200/690-1200/750-1200 | 610-1200/640-1200/690-1200 | Overlapping/similar ranges. | 585-1200 | Yes (Analysis 6) |
| Vascular Lesions Energy | 20-50 | 10-42 | 10-44 | Overlapping/similar ranges. | 20-50 | Yes (Analysis 6) |
| Vascular Lesions Pulse Duration | 3-10 | 3-8 | 3-9 | Overlapping/similar ranges. | 3-10 | Yes (Analysis 6) |
2. Sample Size Used for the Test Set and Data Provenance
This is a 510(k) submission based on substantial equivalence, not a de novo clinical study for device performance validation. Therefore, there is no specific "test set sample size" as would be associated with a typical clinical trial evaluating a new device's performance. The study described is a "Bench Test" outlined in item 7: "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
- Sample Size: Not applicable in the context of a clinical test set. The "samples" would be the device itself and its components tested against design specifications and international standards.
- Data Provenance: The bench tests were conducted by the manufacturer, Beijing Honkon Technologies Co., Ltd., which is based in Beijing, P.R. China. The data would be considered retrospective in the sense that it's a comparison to already approved predicate devices and adherence to established standards rather than data from a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since there was no clinical "test set" in the traditional sense as part of this 510(k) submission, no experts were explicitly used to establish ground truth for a test set. The "ground truth" for proving substantial equivalence lies in the established safety and effectiveness profiles of the legally marketed predicate devices and the international standards (IEC 60601-1, IEC 60601-1-2) that the proposed device complies with.
4. Adjudication Method for the Test Set
Not applicable. As noted above, there was no clinical test set requiring expert adjudication for establishing ground truth. The "adjudication" in a 510(k) process is the review by the FDA to determine if substantial equivalence has been demonstrated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices or those requiring human interpretation of results, and it's not a standard requirement for IPL devices seeking 510(k) clearance based on substantial equivalence to existing devices for aesthetic applications. Therefore, there is no reported effect size for how much human readers improve with AI vs without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is an Intense Pulsed Light system, a physical medical device, not a software algorithm. Therefore, "algorithm only" performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is established by:
- Predicate Device Equivalence: The safety and effectiveness established for the legally marketed predicate devices (K122995 and K093627). The proposed device is deemed substantially equivalent because its technological characteristics and intended use are highly similar, and any minor differences are argued not to affect safety or effectiveness.
- Compliance with International Standards: Adherence to recognized consensus standards for medical electrical equipment (IEC 60601-1 and IEC 60601-1-2). These standards provide a benchmark for fundamental safety and essential performance.
In essence, the "ground truth" is that the predicate devices are safe and effective, and the new device is sufficiently similar to share that "truth."
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The submission is for a physical IPL device based on established technology.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.