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CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

HF electrosurgical Part : The Secret Pro is intended for use in dermatologic and general surgical procedures for electro coaqulation and hemostasis

Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro coagulation and hemostasis

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The provided documents are FDA 510(k) clearance letters for the "Secret Pro" device. These letters indicate the administrative correction of a previous letter and the initial clearance for the device. However, they do not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about standalone performance or comparative effectiveness studies.

The letters primarily focus on:

• Notifying the applicant of an administrative change.
• Confirming the device's substantial equivalence to predicate devices.
• Listing the device's indications for use.
• Reminding the applicant of regulatory requirements (e.g., general controls, quality system regulation, adverse event reporting).

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, details from a specific study report (e.g., a clinical validation study or performance testing report) would be needed, which are not present in these FDA clearance documents.

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