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The StrataPulse and StrataPulse TS IPL Systems are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:

• Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen.
• Treatment of:
  • Moderate inflammatory acne vulgaris
  • Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles).
  • Cutaneous lesions including scars
  • Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins and venous malformations.
• Integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during and after light treatment in general aesthetic dermatologic and plastic surgery procedures to:
  • Reduce pain during light treatment (via partial anesthesia from cooling).
  • Reduce discomfort during and/or associated with light treatment
  • Minimize thermal injury, including thermal necrosis, to non-targeted skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hype- and/or hypo pigmentation.
  • Allow the use of higher light or laser fluences for light treatments (such as for hair reduction and the treatment of vascular or pigmented lesions)
  • Reduce potential side effects of light treatment (such as for hair reduction and the treatment of vascular or pigmented lesions)

The StrataPulse IPL system is an intense pulsed light system. This device uses computer controlled power supply, xenon flash-lamp and band-pass filter to generate light pulses of prescribed duration, intensity and spectral distribution. The device is also equipped with cooling systems to maintain both the treatment head and the internal structure of the device at appropriate and safe temperatures. The light pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the device. More specifically, the computer software regulates in a prescribed fashion the outflow of power from the power supply to the flash-lamp such that a flash of intense pulsed light is generated.

The provided text is a 510(k) Summary for the StrataPulse IPL System. It explicitly states in section "6. Performance Data" that "No performance data is required for this Class II device nor requested by the Food and drug Administration (Office of Device Evaluation)."

Therefore, the device's acceptance criteria and the study proving it meets these criteria are not detailed in this document. The submission relies on substantial equivalence to a legally marketed predicate device (Accelawave System: K082484) rather than new performance data.

Consequently, most of the requested information cannot be extracted from the provided text.

Here's an overview based solely on the information available:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as performance criteria are not required. The general acceptance criteria are "substantial equivalence" to a predicate device.
   • Reported Device Performance: Not reported as no performance data was required/submitted.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable as no performance study was conducted or submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable as no performance study was conducted or submitted that required establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as no performance study was conducted or submitted that required adjudication.

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:

   • No MRMC comparative effectiveness study was done. This is an IPL device, not an AI or diagnostic imaging device that typically involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable as this is an IPL device, not an algorithm/AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable as no performance study was conducted or submitted that required ground truth.

8. The sample size for the training set:

   • Not applicable as no performance study was conducted or submitted, and the device is not an AI/ML algorithm that would typically have a training set.

9. How the ground truth for the training set was established:

   • Not applicable as no performance study was conducted or submitted, and no training set was used.

The submission focuses primarily on comparing the StrataPulse IPL System's technical characteristics and indications for use to the legally marketed Accelawave System to demonstrate substantial equivalence. The key comparison points are:

The conclusion states that the pertinent characteristics of the StrataPulse IPL system are "substantially similar to the legally marketed devices" and it "does not result in different performance or raise new questions of safety or efficacy."

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