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• The POLYLASE LP PULSED DUAL OUTPUT LASER is intended to effect 1. TEMPORARY HAIR REDUCTION in skin types I-IV with 755 nm output wavelength) and skin types IV-VI with 1064 nm output wavelength.
• 2. The POLYLASE LP PULSED DUAL OUTPUT LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-III with use of 755 nm wavelength and skin types IV and V with use of 1064 nm wavelength through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
• 3. FOR PHOTOCOAGULATION AND HEMOSTASIS OF DERMATOLOGICAL VASCULAR LESIONS with 1064 nm output wavelength.
• 4. FOR INCISION/EXCISION OF SOFT BODY TISSUES IN DERMATOLOGY with 1064 nm output wavelength.
• 5. FOR NONABLATIVE WRINKLE REDUCTION AND SKIN COLLAGEN REJUVENATION with 1064 nm output wayelongth

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This document is a 510(k) premarket notification approval letter for the Polylase™ LP Dual Output Alexandrite and Nd: Y AG Laser. It does not contain information about acceptance criteria or a study proving device performance in the format requested. The document primarily serves as an FDA clearance for the device to be marketed, based on its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information as it is not present in the provided text.

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1. The EPY-50 PULSED Nd: YAG LASER is intended to effect TEMPORARY HAIR REDUCTION in skin types I-IV.
2. The EPY-50 PULSED Nd: YAG LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
3. VASCULAR LESIONS.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the EPY-50 PULSED Nd:YAG LASER. It does not contain the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for proving the device meets acceptance criteria.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Lists the indications for use for the device.
• Outlines general regulatory requirements.

Therefore, I cannot provide the requested table and study details based on the input document.

Ask a specific question about this device

Ask a specific question about this device