(205 days)
Not Found
No
The document describes a laser system with different wavelengths and delivery methods, focusing on the physical properties and applications of the laser energy. There is no mention of AI or ML in the intended use, device description, or any of the provided sections.
Yes
The device is described with multiple medical indications across various specialties, including dentistry, dermatology, ENT, general surgery, podiatry, ophthalmology, and gynecology, for procedures such as incision, excision, ablation, coagulation, and treatment of various lesions and conditions. This broad range of medical applications for treating diseases or conditions classifies it as a therapeutic device.
No
Explanation: The device description and intended use clearly state that this is a laser system designed for various surgical procedures, including cutting, excision, vaporization, and coagulation of tissues. It is a therapeutic device, not one that gathers or analyzes data for diagnostic purposes.
No
The device description clearly outlines a hardware-based laser system with physical components like laser sources, an articulated arm, handpieces, and a footswitch. While it mentions "Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser pulse duration," this technology is integrated into the hardware and controls the physical laser output, not a standalone software function performing a medical purpose.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The Fotona Light Walker Laser System Family is a surgical laser system. It uses laser energy to directly interact with and modify tissues within the body (intra-oral, skin, organs, etc.).
- Intended Use: The intended uses listed are all surgical procedures performed directly on the patient's body, not laboratory tests on samples.
The device description and intended uses clearly indicate that this is a therapeutic device used for surgical interventions, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
Er:YAG 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
- 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
- Cutting, shaving, contouring and resection of oral osseous tissue (bone)
- Osteotomy, osseous crown lengthening, osteoplasty
- Apicectomy surgery
- Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curetage
Er:YAG 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;
- Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectorny;
- 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, matrixectorny;
- Ophthalmology Indications: Soft tissue surrounding the eye;
- Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;
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
- 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 canal therapy
- Removal of post-surgical granulations
- Soft tissue crown lengthening
- Sulcular debridement or soft tissue curettage (removal of diseased or inflamed 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
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. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
- General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal.
- Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas
The Fotona Light Walker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
Product codes (comma separated list FDA assigned to the subject device)
PDZ, GEX
Device Description
The Fotona Light Walker Laser System Family is based on Er: YAG (2940 nm) and Nd: YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er: YAG and Nd: YAG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical manual or scanner hand piece (in the case of the Nd: YAG laser). Optionally, the Nd: YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser pulse duration. The user activates laser emission by means of a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra-oral, dental, skin, ENT, oral/maxillofacial, general soft tissue, podiatry, eye (soft tissue surrounding), gynecological, nail.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K101817, K093162, K101306, K090126, K113702, K103626, K093547
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
5. 510(k) Summary Submitter's Name:
Contact Person:
Sincerely yours, FOR Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
4. Indications for Use Statement
510(k) Number K121508
Device Name: LightWalker Family
Indications For Use:
Er:YAG 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 l
- 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
- Cutting, shaving, contouring and resection of oral osseous tissue (bone) ﺍ
- Osteotomy, osseous crown lengthening, osteoplasty ।
- Apicectomy surgery l
- Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curetage
Er:YAG laser (2940 nm wavelength) in dermatology and other surgical areas:
- Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin l tags, keratoses and skin resurfacing;
- ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
- Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectorny; ।
- 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, matrixectorny; l
- Ophthalmology Indications: Soft tissue surrounding the eye; ເ
- Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;
Neil R Ogden 2012.12.12 08:47:12 -05'00'
(Division Sign-Off)
Division of Surgical Devices
510(k) Number
8
Nd:YAG laser (1064 nm wavelength) in dentistry:
-
Excisional and incisional biopsies l
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
Incision and drainage of abscess
Laser assisted uvulopaletoplasty (LAUP)
-
। Operculectomy
Oral papillectomies -
Pulpotomy and pulpotomy as an adjunct to root canal therapy ।
-
l. Reduction of denture hyperplasia
-
Reduction of gingival hypertrophy l Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
-
Removal of post-surgical granulations i
Soft tissue crown lengthening
Sulcular debridement or soft tissue curettage (removal of diseased or inflamed 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 ı Treatment of aphtous ulcers
Vestibuloplasty -
Neil R Ogden 2012.12.12 08:47:38 -05'00'
(Division Sign-Off)
Division of Surgical Devices
K121508 510(k) Number
9
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. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins
Treatment of wrinkles
Treatment of mild to moderate inflammatory acne vulgaris
General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal.
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft ।
tissue) including: Matrixectomy
Periungual and subungual warts
Plantar warts
Radical nail excision
Neuromas
The Fotona Light Walker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
Prescription Use: X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2012.12.12 08:48:11 -05'00'
(Division Sign-Off)
Division of Surgical Devices
510(k) Number K121508