(87 days)
The VE2000 device is indicated for use in surgical, aesthetic applications in permanent hair reduction of benign pigmented lesions and benign vascular lesions.
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 regimen
The VE2000 device are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 480nm-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 penetration without using excessive energy levels and enables targeting of specific chromophores.
Based on this,The VE2000 device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair removal, reduction of pigmented lesions and vascular lesions.
The provided document outlines the substantial equivalence (SE) determination for the VE2000 IPL Therapy Machine (K161286) to a predicate device (Intense Pulsed Light (IPL) Systems, K122995).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" for clinical performance. Instead, it demonstrates substantial equivalence by comparing the proposed VE2000 device's performance parameters and intended uses to those of a legally marketed predicate device. The underlying "acceptance criteria" are therefore implied to be that the proposed device performs comparably to the predicate device for its stated indications.
| Parameter/Characteristic | Acceptance Criteria (Implied from Predicate) | Reported Device Performance (VE2000) | Meets Criteria | Notes on Comparison |
|---|---|---|---|---|
| Product Code | ONF | ONF | Yes | Substantially Equivalent (SE) |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | Yes | SE |
| Class | II | II | Yes | SE |
| Intended Use (Overall) | Surgical, aesthetic, and cosmetic applications in permanent hair removal, reduction of pigmented lesions, acne therapy, freckles, vascular lesions and facial blemish. | Surgical, aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions. | Yes | SE (Proposed device has a narrower IFU scope, making it SE) |
| Light Source | Intense pulsed light | Intense pulsed light | Yes | SE |
| Wavelength | 430-1200nm, 530-1200nm, 640-1200nm, Optional: 480-1200nm, 560-1200nm, 590-1200nm, 690-1200nm, 750 -1200nm | 480nm-1200nm, 590nm-1200nm, 640nm-1200nm | Yes | SE (Ranges overlap substantially, and proposed device ranges fall within or are comparable to predicate's capabilities) |
| Delivery System | Sapphire | Sapphire | Yes | SE |
| Energy Density | 10-60 J/cm² | 1-50 J/cm² | Yes, with analysis | Analysis 1: "the difference is very slight, and only in the range, but because the proposed device has narrow IFU scope and same IFU setting with the predicate device, the current parameter range is available for the indication for use of proposed device." Considered SE. |
| Pulse Delay | 5-50 ms | 1-50 ms | Yes, with analysis | Analysis 1: "the difference is very slight, and only in the range... Considered SE. |
| Pulse Width | 1-20 ms | 1-25 ms | Yes, with analysis | Analysis 1: "the difference is very slight, and only in the range... Considered SE. |
| Max. Power | 2000 W | 2200 W | Yes | SE (Slight increase, likely not detrimental for a Class II device) |
| Spot Size | MED-210: 15mmX50mm (optional: 12mmX33mm, 15mmX35mm); MED-230: A: 12mm X33mm; B: 15mmX50mm (optional: 15mmX35mm) | 12x30mm | Yes, with analysis | Analysis 1: "the difference is very slight, and only in the range... Considered SE. |
| Permanent Hair Reduction Settings: | ||||
| - Wavelength Range (nm) | 640-1200/690-1200/750-1200 | 640-1200 | Yes | Comparison shows overlap and acceptable ranges. |
| - Energy Range (J/cm²) | 10-44 | 10-44 | Yes | SE |
| - Pulse Width (ms) | 3-14 | 3-14 | Yes | SE |
| - Pulse Delay (ms) | 16-32 | 16-32 | Yes | Comparison shows overlap and acceptable ranges. |
| - Spot Size (mm) | 12mm X33mm; 15mmX50mm; 15mmX35mm | 12x30mm | Yes | Comparison shows overlap and acceptable ranges. |
| Pigmented Lesions Settings: | ||||
| - Wavelength Range (nm) | 480-1200/530-1200/560-1200 | 480-1200 | Yes | Comparison shows overlap and acceptable ranges. |
| - Energy Range (J/cm²) | 12-44 | 12-44 | Yes | SE |
| - Pulse Width (ms) | 3-9 | 3-9 | Yes | Comparison shows overlap and acceptable ranges. |
| - Pulse Delay (ms) | 16-32 | 16-32 | Yes | Comparison shows overlap and acceptable ranges. |
| - Spot Size (mm) | 12mm X33mm; 15mmX50mm; 15mmX35mm | 12x30mm | Yes | Comparison shows overlap and acceptable ranges. |
| Vascular Lesions Settings: | ||||
| - Wavelength Range (nm) | 530-1200/560-1200/590-1200 | 590-1200 | Yes | Comparison shows overlap and acceptable ranges. |
| - Energy Range (J/cm²) | 10-42 | 10-42 | Yes | SE |
| - Pulse Width (ms) | 3-8 | 3-8 | Yes | Comparison shows overlap and acceptable ranges. |
| - Pulse Delay (ms) | 16-32 | 16-32 | Yes | Comparison shows overlap and acceptable ranges. |
| - Spot Size (mm) | 12mm X33mm; 15mmX50mm; 15mmX35mm | 12x30mm | Yes | Comparison shows overlap and acceptable ranges. |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Yes | SE |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Yes | SE |
| Patient Contact Material | Handpiece | Handpiece | Yes | SE |
| Cytotoxicity | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | Yes | SE |
| Irritation | No irritation to skin (ISO 10993-10) | No irritation to skin (ISO 10993-10) | Yes | SE |
| Sensitization | No significant evidence of sensitization (ISO 10993-10) | No significant evidence of sensitization (ISO 10993-10) | Yes | SE |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no test set sample size or data provenance related to clinical performance described. The safety and effectiveness determination is based on non-clinical testing and comparison to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical study was conducted and no clinical test set was used for performance evaluation, this information is not applicable and is not provided in the document.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission relies on non-clinical testing and substantial equivalence to a predicate device, without involving human readers or AI assistance in a comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an IPL Therapy Machine, not an algorithm, and its performance evaluation for substantial equivalence was based on non-clinical testing and comparison to a physical predicate device, not standalone algorithmic performance.
7. The Type of Ground Truth Used
The "ground truth" for the substantial equivalence determination for this device is primarily established by:
- Compliance with recognized electrical safety and EMC standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57.
- Biocompatibility testing: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
- Direct functional and parametric comparison to a legally marketed predicate device (K122995) for intended use, light source, wavelength, energy density, pulse characteristics, and spot size. The predicate device itself has presumably been accepted by the FDA based on its own evidence of safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device is an IPL therapy machine, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.