(204 days)
The PicoWay laser system is indicated for the following at the specified wavelength:
- · 532 mm: Removal of tattoos for Fitzpatrick Skin Types I-III to treat the following tattoo colors: red, yellow and orange.
- · 730 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
- · 785 mm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
· 1064 nm: Removal of tattoos for all Fitzpatrick Skin Types to treat the following tattoo colors: black, brown, green, blue and purple.
The Pico Way laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV.
The Resolve handpieces (532 nm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.
The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented for Fitzpatrick Skin Types I-IV.
The PicoWay laser system is indicated for the following at the specified wavelengths:
532 nm :
· Treatment of Melasma for Fitzpatrick Skin Types I-IV.
· Treatment of café au lait macules (CALMs) for Fitzpatrick Skin Types I-IV.
- · Treatment of Lentigines for Fitzpatrick Skin Types I-IV.
730 nm:
· Treatment of Lentigines for Fitzpatrick Skin Types I-IV.
1064 nm:
- · Treatment of Melasma for Fitzpatrick Skin Types I-IV.
- · Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV.
The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, or 730 nm, at extremely short duration in the range of 240-500 (ps). The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 / 532nm wavelengths. The outputs of the two lasers are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532nm or 1064nm wavelengths. The 532nm or 1064nm output energy is delivered to the skin through an Articulated Arm and Zoom Handpiece (HP) delivery system. There are also 3 hand pieces (Resolve), one for 1064nm and two for 532nm (low energy and high energy), which deliver a 10 x 10 array of focused spots to the skin and 1 Axicon hand piece (Resolve Fusion) for 532nm, which delivers a 10 x 10 array of focused and ring spots to the skin.
The provided document describes the Candela PicoWay Laser System (K220853) and its substantial equivalence to a predicate device (K191685). The primary difference is the addition of new indications for benign pigmented lesions. The document does not refer to the device as an "AI device" or an "algorithm," but rather a laser system. Therefore, some of the requested information regarding AI device testing (e.g., human-in-the-loop performance, effect size of human improvement with AI, training set details, expert qualifications for ground truth in a test set, adjudication methods) is not directly applicable.
However, based on the information provided, here's a summary of the acceptance criteria and the study that supports the expanded indications for the PicoWay Laser System, focusing on the clinical evidence for the new indications.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the expanded indications are implied by the clinical studies demonstrating the safety and effectiveness of the PicoWay Laser System for these conditions. The reported device performance is derived from the outcomes of these clinical studies.
| Acceptance Criteria (Implied) | Reported Device Performance (from Clinical Studies) |
|---|---|
| Expanded Indications Safety & Effectiveness: Device is safe and effective for new benign pigmented lesion indications (Nevus of Ota, café au lait macules (CALMs), melasma, and lentigines) for Fitzpatrick Skin Types I-IV, at specified wavelengths and handpieces. | General Safety: Treatments were well tolerated, and no device-related adverse events were reported in the investigator-initiated study for melasma. The systematic literature review implies satisfactory safety for the other indications as it informed the conclusion of substantial equivalence. |
| Melasma Treatment Efficacy: Statistically significant improvement in melasma. | Melasma: Statistically significant improvement (p |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.