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510(k) Data Aggregation
(121 days)
SPEED 808 DIODE LASER SYSTEM
The new device Speed 808 Diode Laser System is intended for use in dermatologic and general surgical procedures.
The Speed 808 Diode Laser System is indicated for hair removal, permanent hair reduction.
The 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 Speed 808 Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Speed 808 Diode Laser System are new devices for 510(k) submission and share the similar indication for use and safety compliance, similar design features and functional features with the predicate devices.
The complete system consists of a console, a handpiece connected to the system by an umbilical cord and a footswitch. There are two important components in the handpiece: a diode laser inserted in the handpiece and a sapphire-made aperture with an area of 10mmX10mm through which laser energy is emitted. A cooling system effectively works on the sapphire-made aperture and can ensure enough and continuous protection of skin. The handpiece is pressed against the patient's skin and a pulse of laser is delivered. To initiate energy output, the system requires the activation of the handpiece trigger or the footswitch. Laser specifications and other system features are controlled from the Operating Buttons and LCD screen on top of the console, which provide interface with the system computer.
The Speed 808 Diode Laser System is intended for hair removal and permanent hair reduction. The manufacturer states that the device is substantially equivalent to the predicate device, Modified Alma Lasers Family of Soprano XL™ Multi-Application Platforms.
Here's a breakdown of the information requested, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for hair removal or permanent hair reduction. Instead, it relies on substantial equivalence to a predicate device.
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Intended Use | "hair removal, permanent hair reduction" | "Speed 808 Diode Laser System is intended for use in dermatologic and general surgical procedures. The Speed 808 Diode Laser System is indicated for hair removal, permanent hair reduction." |
| Permanent Hair Reduction Definition | "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 device's indication aligns with this definition. No specific performance data (e.g., percentage reduction) is provided. |
| Skin Types | "intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin" | The device's indication aligns with this. No specific performance data for different skin types is provided. |
| Safety and Effectiveness | Substantial equivalence to predicate device (Modified Alma Lasers Family of Soprano XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] (K102716)) in terms of "indications for use, design features, functional features, same safety compliance." | "Speed 808 Diode Laser System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues." |
| Compliance with Standards | IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2, UL 60601-1:2003 R6.03 | "Speed 808 Diode Laser System is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards..." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No Clinical Information is required." This indicates that no clinical test set with human subjects was used for this 510(k) submission. The evaluation was 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 Qualifications of Those Experts
Since no clinical test set was used, there were no experts used to establish a ground truth for a test set. The regulatory body (FDA) reviewed the non-clinical data and the claim of substantial equivalence.
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 did not involve clinical studies with human readers or 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 a laser system, not an AI algorithm. The testing was non-clinical, focusing on design specifications and compliance with standards.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Engineering and design specifications: The device was tested to meet its design specifications.
- Compliance with international and national standards: The device underwent testing to ensure it met relevant safety and performance standards (e.g., IEC, UL).
- Substantial equivalence to a legally marketed predicate device: The fundamental "ground truth" for regulatory clearance was the demonstration that the device is as safe and effective as the predicate device already approved for marketing, without raising new issues.
8. The Sample Size for the Training Set
Not applicable. This device is a physical laser system, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this device does not utilize a training set in the AI sense.
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