(392 days)
Er: Y AG laser (2940 nm wavelength) in dentistry:
- Intra-oral soft tissue surgery (incision, excision, ablation coagulation) -
- -Leukoplakia
- = Pulpotomy as adjunct to root canal retreatment
- Pulp extirpation -
- Removal of fibromae -
- Removal of granulated tissue ﺳﯿﺴﺖ
- Caries removal, cavity preparation, enamel roughening -
- Sulcular debridement -
- Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement
- ー Cutting, shaving, contouring and resection of oral osseous tissue (bone)
- Osteotomy, osseous crown lengthening, osteoplasty -
- Apicectomy surgery -
Er: Y AG laser (2940 nm wavelength) in dermatology and other surgical areas:
- Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing;
- ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; l
- Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy; -
- General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation;
- Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; -
Nd:YAG laser (1064 nm wavelength) in dentistry:
- -Excisional and incisional biopsies
- Excision and vaporization of herpes simplex I and II -
- Exposure of unerupted teeth -
- Fibroma removal —
- Frenectomy and frenotomy -
- Gingival troughing for crown impressions -
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision =
- Hemostasis -
- Implant recovery J
- Incision and drainage of abscess -
- Laser assisted uvulopaletoplasty (LAUP) -
- Operculectomy =
- Oral papillectomies =
- Pulpotomy and pulpotomy as an adjunct to root canal therapy -
- Reduction of denture hyperplasia -
- -Reduction of gingival hypertrophy
- Removal of filling material such as gutta percha or resin as adjunct treatment during root e canal therapy
- Removal of post-surgical granulations ।
- Soft tissue crown lengthening =
- Sulcular debridement or soft tissue curettage (removal of diseased or imflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility)
- Tissue retraction for impression -
- Treatment of aphtous ulcers -
- Vestibuloplasty -
- Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
Nd: YAG laser (1064 nm wavelength) in dermatology and other surgical areas:
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited । to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
- Treatment of wrinkles -
- Treatment of mild to moderate inflammatory acne vulgaris
The Fotona Fidelis III laser system family is based on Er: Y AG (2940 nm) and Nd: YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er.Y AG and Nd: Y AG crystals. A red diode aiming beam (650 mm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical hand piece (in the case of the Nd: YAG laser).
The Er.Y AG laser is capable of delivering up to 1.5 J of laser energy in pulses with durations of up to 1000 us and frequencies (repetition rates) of up to 50 Hz. The maximum average output power is 20 W.
For aesthetic indications, the Nd:YAG laser is capable of delivering laser fluences up to 300 1/cm² in pulses with durations of up to 25 ms. For dental indications, it is capable of delivering laser pulses with durations of up to 320 us, frequencies (repetition rates) up to 100 Hz and a maximum output power of 15 W.
Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows ultimate control of the laser energy and the laser pulse duration. This ensures treatment precision, patient comfort, safety and ease-of-use in all treatments.
This is an FDA 510(k) K070355 premarket notification for the Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family. This document is a "Substantial Equivalence" determination letter. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria derived from a performance study.
Instead, this type of document is issued when a new device is found to be "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use and technological characteristics as the predicate device(s), or if there are differences, they do not raise different questions of safety and effectiveness.
The document lists the "Indications for Use" for the Fotona Fidelis III laser system, which covers a wide range of applications in dentistry, dermatology, and general/plastic surgery. It then identifies several predicate devices (listed as a-h) to which the Fotona Fidelis III is considered substantially equivalent.
Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets those criteria because this document does not contain that type of information. The FDA's substantial equivalence determination does not rely on new performance studies demonstrating achievement of specific acceptance criteria. Instead, it relies on demonstrating that the new device is as safe and effective as pre-existing, legally marketed devices.
§ 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.