(106 days)
The SLIM Evolution II CO2 Laser 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.
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
MiXto fractional scanner only for treatment of wrinkles and skin resurfacing
Dental procedure including.
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.
Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.
Otorhinolaryngology (ENT) procedures.
Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.
Gynecology
Treatment of condyloma acuminata, cervical intraevithelial 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
SLIM Evolution II CO2 Laser and Delivery Device Accessories.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a medical device called "SLIM Evolution II CO2 Laser and Delivery Device Accessories."
It mainly discusses:
- The FDA's determination of substantial equivalence to predicate devices.
- Regulatory requirements and general controls provisions.
- Specific indications for use of the device across various medical specialties (Dermatology, Plastic Surgery, General Surgery, Dental, Podiatry, Otorhinolaryngology, Gynecology).
There is no mention of:
- Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
- A study design (e.g., test set, sample size, data provenance).
- Ground truth establishment details (experts, adjudication, type of ground truth).
- Standalone algorithm performance or human-in-the-loop studies.
- Training set details.
§ 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.