(58 days)
785 nm laser source
Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064 & 532 nm laser sources in Q-Switched, nanosecond mode
Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to:
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- · Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
- · Treatment of benign vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- Cherry angioma
- Spider nevi
- · Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-Iait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
- · Treatment of seborrheic keratosis
- · Treatment of post inflammatory hyperpigmentation
- · Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- · Removal of dark ink (black, blue and brown) tattoos
- · Removal of benign pigmented lesions including;
- nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
- · Treatment of common nevi
- · Removal or lightening of unwanted hair
- · Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064nm laser source in thermal mode (long-pulse) Intended for:
- Treatment of wrinkles
- · Treatment of mild to moderate inflammatory acne vulgaris
TORO device is a DEKA laser system with a wide choice of emission modes, ranging from picosecond to hundreds of microseconds of pulse duration.
The available sources are Nd:YAG lasers at 532 nm and 1064 nm, operating in Q-switched mode, and Ti:Sapphire laser at 785 nm operating in the Picosecond pulse mode.
The Q-switched laser at 1064 nm can also operate in Thermal mode, delivering pulses of hundreds of microseconds.
The laser beam generated by the source is then optically coupled to the articulated arm with a handpiece plugged at its end and delivered to the Patient.
The provided text does not contain information about acceptance criteria for a medical device's performance or a study proving that a device meets those criteria. The document is a 510(k) premarket notification decision letter from the FDA regarding the "Deka Toro" laser system.
Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics (e.g., wavelength, pulse duration, energy, fluence, spot size, repetition rate), and compliance with electrical safety, EMC, and software validation standards.
Therefore, I cannot fulfill your request for the following information:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document explicitly states under "Clinical Performance Data: None," and presents "Non-Clinical Performance Data" which pertains to electrical safety, EMC, and software validation, not clinical performance or efficacy studies against defined acceptance criteria.
§ 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.