(156 days)
The SLIM Evolution Family of CO2 Lasers and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Dermatology, Plastic Surgery and General Surgery procedures including but not limited to -
Laser skin resurfacing
Treatment of furrows and wrinkles
Removal of skin tags, actinic keratosis, acne scars, keloids, tattos,
telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty
Site preparation for hair transplants
Dental procedure including but not limited to -
Periodontal procedures such as -- gingivectomy, removal of hyperplasias,gingivoplasty (incision and excision) Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign/malignant lesion ablation, operculectomy and homeostasis
Podiatry procedures including but not limited to -
Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures including but not limited to -
Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.
Gynecology
Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia. Laparoscopic treatment endometrial lesions, ablation of endometriosis, fimbroplasty,
Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids
The SLIM Evolution Family of CO2 Lasers emit a beam of coherent light at the wavelength 10.6 microns in either continuous wave or pulse mode. Each laser consists of a self-contained console, an articulated arm delivery system, a footswitch, safety goggles and warning label set. The main console contains a DC-excited sealedoff CO2 gas tube, micro-controller, articulated arm mount, internal closed circuit cooling system and power supply. The console has an on-off key switch and emergency stop push button. The articulated arm connects the console to focusing handpieces, waveguides, scanner and micromanipulator delivery accessories. Refer to the enclosed brochure and instruction manual for complete published information.
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Table of Acceptance Criteria and Reported Device Performance:
The provided document does not specify quantitative acceptance criteria or provide
performance metrics for the SLIM Evolution Family of CO2 Lasers. The submission states
"Performance Data: None provided" and "Clinical Data: None provided."
Therefore, a table of acceptance criteria and reported device performance cannot be
generated from the provided text. -
Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document explicitly states "Performance Data: None provided" and
"Clinical Data: None provided." This indicates that no specific test set data was
used or presented for the device's performance evaluation in the 510(k) submission. -
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. As no performance or clinical data was provided, no ground truth
establishment for a test set was conducted or reported in this submission. -
Adjudication Method for the Test Set:
Not applicable. No test set or associated adjudication method was mentioned or
described in the provided document. -
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. The document concerns a CO2 laser device for surgical
applications, not an AI-powered diagnostic or assistive technology for human readers.
Therefore, an MRMC study related to AI assistance is irrelevant to this submission. -
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a physical CO2 laser system, not an algorithm.
Standalone algorithmic performance is not relevant to this type of medical device submission. -
The Type of Ground Truth Used:
Not applicable. No performance or clinical data was provided, so no type of ground
truth was used or documented in this submission. The device's substantial
equivalence was based on comparison to legally marketed predicate devices, not on
independent performance testing against a defined ground truth. -
The Sample Size for the Training Set:
Not applicable. The device is a physical CO2 laser system. There is no mention of a
training set in the context of machine learning or algorithm development. -
How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an algorithm, the establishment of
ground truth for such a set is not relevant to this submission.
§ 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.