(149 days)
The SkinLaser System is indicated for incision, excision, coagulation and vaporization of soft tissue.
In general surgery, dermatologic and plastic surgery, all soft tissues are included in this indication: skin, subcutis, breast, abdominal and striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymph vessels and nodes, and internal organs and glands.
In gynecologic and urologic surgery indications include endoscopic, intraabdominal and externally accessed (free-hand) gynecological and urological tissues, structures, obstructions, strictures, tumors, and other lesions. Only palliative treatment and partial removal of neoplastic tissue should be assumed.
In gastroenterology indications include destruction of polyps, lesions, varices, tumors, and for treatment of hemorrhages.
In pulmonology surgery indications include flexible or a rigid endoscopic and free-hand access and treatment of soft tissue lesions, obstructions, tracheal stenosis, and tumors.
The SkinLaser System is substantially equivalent to continuous wave (CW) and pulsed CW surgical lasers in the wavelength range of 800nm to 1064nm. Such systems have been in surgical use for many years offering broad multi-specialty, multi-procedure applications. The laser deliver system includes both contact and non-contact devices.
This document is a 510(k) summary for a medical device called "SkinLaser System". It does not describe an acceptance criteria or a study proving that the device meets an acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to other existing devices on the market.
Therefore, I cannot extract the requested information from the provided text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample size or data provenance for a test set.
- Details on experts used to establish ground truth.
- Information on adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone algorithm performance study.
- The type of ground truth used.
- Training set sample size or how its ground truth was established.
The document primarily provides:
- Device Identification: Trade Name (SkinLaser), Common Name (Surgical/Medical Solid State Laser System), 510(k) Number (K980501).
- Substantial Equivalence Claim: The SkinLaser System is substantially equivalent to continuous wave (CW) and pulsed CW surgical lasers in the wavelength range of 800nm to 1064nm, and lists several predicate devices.
- Indications for Use: Broad applications in general surgery, dermatologic and plastic surgery, gynecologic and urologic surgery, gastroenterology, and pulmonology.
- FDA Clearance Letter: Confirms the device's substantial equivalence and class (Class II, product code GEX), and outlines regulatory responsibilities.
§ 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.