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510(k) Data Aggregation
(107 days)
Intense Pulsed Light Therapy Device (MMABM-1)
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(87 days)
Intense pulsed light therapy device
The Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal. 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 Intense pulsed light therapy device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 650-1200nm. 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 Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal.
The document is a 510(k) Summary for an Intense Pulsed Light (IPL) therapy device (Model: FI-L06) seeking FDA clearance for permanent hair removal. It compares the proposed device to a predicate device (K192519) to establish substantial equivalence.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format for clinical performance. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications. The key performance comparison is presented in tables 6-2 and 6-3.
| Feature/Parameter | Proposed Device Performance | Predicate Device (K192519) Performance | Difference Analysis |
|---|---|---|---|
| Product Code | ONF | ONF | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | II | II | SAME |
| Indication for Use | Surgical and aesthetic applications in permanent hair removal. Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment. | Surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment. | SAME (for permanent hair removal indication) |
| Light source | Intense pulsed light (Xenon Lamp) | Intense pulsed light | Analysis 1: Both use Xenon lamps; considered SAME type. |
| Wavelength | 650-1200nm | 520-650nm, 800-1200nm, 540-800nm, 640-1200nm | SAME (for hair removal, proposed device's range is within the broader predicate ranges) |
| Deliver system | Sapphire | Sapphire | SAME |
| Energy density | 1-50J/cm² | 1-50 J/cm² | SAME |
| Pulse Width | 0.1-25ms | 1-25ms | SAME (within the common range) |
| Max. Power | 1500W | 3500VA | Analysis 2: Different, but non-clinical tests (AAMI/ANSI/ES 60601-1 and IEC 60601-1-2) showed no safety/effectiveness issues. |
| Spot size | 8×40mm | Small: 40×12 mm, Large: 46×16mm, Ex-Large: 60×20mm | Analysis 3: Different, but only affects treatment area, not therapeutic effect. |
| Wavelength Range (for Hair removal) | 650-1200 | 640-1200 | SAME |
| Energy Range (for Hair removal) | 1-50 | 5-40 | Analysis 4: Slight difference, but within allowable error range of predicate and bench tests support substantial equivalence. |
| Pulse Width (for Hair removal) | 0.1-25 | 1-25 | SAME |
| Spot Size (for Hair removal) | 8×40 | Small: 40×12 mm, Large: 46×16mm, Ex-Large: 60×20mm | Different (same as above for spot size analysis). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission explicitly states: "No clinical study is included in this submission." The evaluation for substantial equivalence relies on non-clinical (bench) testing and comparison to the predicate device's established performance and specifications.
- Data Provenance: Not applicable, as no clinical data was submitted. Non-clinical tests were conducted by the manufacturer, Hebei Zhemai Technology Co., Ltd., in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. No clinical test set requiring expert ground truth was created for this submission. The submission relies solely on non-clinical testing and comparison to an existing predicate device.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was used.
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
- Not applicable. This device is an Intense Pulsed Light therapy device for hair removal, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant for this device type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical IPL therapy machine; it does not involve an algorithm running in a standalone mode without human interaction, nor an AI component to evaluate. Its operation is managed by a user.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical ground truth was established or used as no clinical studies were performed. The "ground truth" for demonstrating substantial equivalence was based on bench testing and comparison against recognized industry standards (IEC 60601-1-2:2020, AAMI/ANSI ES 60601-1: 2012, IEC 60601-2-57: 2011, ISO 10993-5: 2009, ISO 10993-10: 2010, ISO 14971: 2019) and the established specifications and indications for use of the predicate device.
8. The Sample Size for the Training Set
- Not applicable. No AI model or algorithm requiring a training set was part of this submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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