(81 days)
The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is substantially equivalent to the following devices: The Robbins Acrotorque & Bell Hand Engines, the Sharplan Model 1120 CO2 Surgical Laser, and the Sharplan SwiftLase CO2 Flash Scanner Accessory (aka SilkTouch) (preamended, K936109, K941312, and K936109, respectively). It is indicated for incision/excision, ablation/vaporization, coagulation, and debridement of soft tissue in Plastic Surgery/Dermatology. Plastic Surgery/Dermatology procedures encountered are: laser skin resurfacing/dermabrasion, blepharoplasty, rhinophyma, squamous cell carcinoma, buccal hemangioma, telangjectasis, the treatment of wrinkles or rhytides, and scar revision.
The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is a motorized, laser beam deflection system that is attached to a CO2 laser articulating arm. The device redirects a focused laser beam through moving mirrors, within a specified pattern scan area. Similar to the common surgeon's technique of manually scanning a focused beam over a treatment area, the constantly moving beam of the SilkTouch Flash Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels The SilkTouch Flash Scanner has controls for varying the scanned area from 0.9 to 9 mm and completes the scan within 0.05 - 0.45 seconds. This device is used with CO2 handpieces or micromanipulators. When the unit is turned off, the connected laser operates to its specifications and allows incision or manual scanning for vaporization purposes.
This 510(k) summary does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Instead, it focuses on demonstrating substantial equivalence to predicate devices. The document explicitly states:
"The safety and effectiveness of the Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices..."
And later:
"...Sharplan Lasers, Inc. believes that the expanded indications for this device raises no safety or efficacy concerns."
This indicates that the submission relies on the established safety and effectiveness of the existing predicate devices, rather than presenting a de novo study with specific performance acceptance criteria for the new device.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies because this information is not present in the provided text.
§ 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.