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The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses: An accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it. Reduction of pain during Laser or Intense Pulse Light System treatment.

The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a Laser or Intense Pulse Light System for their legally marketed indications. Its handpiece produces a negative pressure over the skin surface just prior to the administration of the treatment beam through it. The chamber of the handpiece produces the negative pressure over the skin surface for a very short duration just prior to firing an intense treatment light pulse or laser beam. The negative pressure results in the flattening of the skin against a highly thermal conductive transparent sapphire window, thereby ensuring tight mechanical contact with the window. The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System consists of a control unit and a handpiece connected together by a 10' flexible hose containing flexible tubing. The flexible hose has a connector at the front of the control unit and is removable by pulling a connector while pressing a latch. The handpiece is ergonomically designed for easy use.

The provided document is a 510(k) summary for the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System. This submission is for an accessory system that works with existing laser or intense pulsed light (IPL) systems for hair removal and pain reduction during treatment.

The document indicates that the submission relies on substantial equivalence to predicate devices (K062589 and K001589) rather than presenting a de novo study with specific performance acceptance criteria for the new device. Therefore, explicit acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial with specific endpoints, are not provided for this 510(k) submission.

Instead, the submission states that:

• "Performance clinical data demonstrates that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System does not introduce new issues of safety and efficacy and therefore is substantially equivalent to the currently legally marketed Inolase Serenity PSF™ (Pneumatic Skin Flattening) System, K062589 and Candela Dynamic Cooling Device, K001589 predicate devices."
• "Performance clinical data demonstrates that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System does not introduce new issues of safety and efficacy."

This suggests that comparison data, likely from clinical observations or existing studies on the predicate devices, was used to support the claim of substantial equivalence. However, the details of these "performance clinical data" are not elaborated in the 510(k) summary.

Given the information provided in the 510(k) summary, it's not possible to populate a table of acceptance criteria and reported device performance directly from a new study, nor can the requested details about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies be provided. This type of information is typically part of a full clinical study report, which is not included in a 510(k) summary.

In summary, the provided 510(k) document is a declaration of substantial equivalence based on prior predicate devices, not a report of a new clinical study with defined acceptance criteria for the submitted device.

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