(145 days)
Not Found
No
The document describes a laser system with different laser technologies and pulse control features. There is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is described as treating various medical conditions and performing surgical procedures in dentistry, dermatology, and other surgical areas, which indicates a therapeutic purpose.
No
The provided text details the intended uses and technical specifications of the LightWalker Er:YAG and Nd:YAG lasers. All listed procedures involve therapeutic interventions (e.g., incision, excision, ablation, coagulation, removal, treatment) rather than diagnosing conditions.
No
The device description clearly states it is a laser system with physical components (laser sources, articulated arm, hand piece, fiber delivery system) and delivers laser energy, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The LightWalker laser system is used for surgical procedures performed directly on the patient's body (in vivo). It uses laser energy to cut, ablate, coagulate, and treat various tissues.
- Intended Use: The intended uses listed are all clinical procedures performed on the patient, not laboratory tests on specimens.
- Device Description: The description details the laser technology and how it delivers energy to the patient's tissues. There is no mention of analyzing biological samples.
Therefore, the LightWalker laser system is a therapeutic and surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LightWalker Er:YAG laser, and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry, for:
- Intra-oral soft tissue surgery (incision, excision, ablation, coagulation) -
- Leukoplakia
- Pulpotomy as adjunct to root canal retreatment -
- -Pulp extirpation
- Removal of fibromae -
- Removal granulated tissue -
- Caries removal, cavity preparation, enamel roughening -
- Sulcular debridement -
- Tooth preparation to obtain access to 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
In dermatology and other surgical areas, for:
- Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, skin tags, . keratoses, verrucae, and skin resurfacing
- ENT Surgery Indications:ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia -
- 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 mosiac verrucae, matrixectomy ー
The LightWalker Nd:YAG laser, and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry, for:
- Excisional and incisional biopsies
- Excision and vaporization of herpes simplex I and II ー
- 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 ー
- 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 ー
- 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 bleeding index, probe depth, attachment loss, and tooth mobility)
- Tissue retraction for impression -
- Treatment of aphtous ulcers ー
- -Vestibuloplasty
In dermatology and other surgical areas, for:
- 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 lessons, such as, but not limited to, port wine stains, hemaongiomae, warts, telengiectasiae, venus lake, leg veins and spider veins
- Treatment of wrinkles ー
- Treatment of mild to moderate inflammatory acne vulgaris -
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Fotona LightWalker laser system family is based on Er:YAG (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.YAG and Nd:YAG 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:YAG 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 J/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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra-oral soft tissue, oral osseous tissue (bone), Epidermal, skin, ENT lesions, oral and glossal lesions, soft tissue (general surgery), warts, plantar, matrixectomy, herpes simplex I and II affected areas, unerupted teeth, fibromas, frenulum, gingiva, abscesses, uvulopaletoplasty affected areas, oral papillae, pulp, denture hyperplasia, post-surgical granulations, periodontal pockets, aphtous ulcers, vestibules, hair, pigmented and vascular lesions, wrinkles, inflammatory acne vulgaris.
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.
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: | Fotona d.d. |
|---|---|
| Stegne 7 | |
| 1210 Ljubljana, Slovenia | |
| Phone: +386 15009100 | |
| Fax: + 386 5009 200 | |
| Contact Person: | Stojan Trošt, QA&RA Manager |
| Phone: +386 1 5009 299 | |
| E-mail: stojan.trost@fotona.com |
NOV 2 2 2010
Date: June 23, 2010
Device Name:
Trade name: Common name: Classification name: Fotona LightWalker Laser System Family Er:YAG/Nd:YAG Surgical Laser Instruments, Surgical, Powered, Laser 79-GEX
DEVICE DESCRIPTION
The Fotona LightWalker laser system family is based on Er:YAG (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.YAG and Nd:YAG 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:YAG 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 J/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.
INTENDED USE
The LightWalker Er:YAG laser, and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry, for:
- Intra-oral soft tissue surgery (incision, excision, ablation, coagulation) -
- Leukoplakia 1
- Pulpotomy as adjunct to root canal retreatment -
- -Pulp extirpation
1
- Removal of fibromae -
- Removal granulated tissue -
- Caries removal, cavity preparation, enamel roughening -
- Sulcular debridement -
- Tooth preparation to obtain access to 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
In dermatology and other surgical areas, for:
- Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, skin tags, . keratoses, verrucae, and skin resurfacing
- ENT Surgery Indications:ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia -
- 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 mosiac verrucae, matrixectomy ー
The LightWalker Nd:YAG laser, and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry, for:
- Excisional and incisional biopsies ت
- Excision and vaporization of herpes simplex I and II ー
- 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 ー
- 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 -
2
therapy
- Removal of post-surgical granulations ー
- 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 bleeding index, probe depth, attachment loss, and tooth mobility)
- Tissue retraction for impression -
- Treatment of aphtous ulcers ー
- -Vestibuloplasty
In dermatology and other surgical areas, for:
- 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 lessons, such as, but not limited to, port wine stains, hemaongiomae, warts, telengiectasiae, venus lake, leg veins and spider veins
- Treatment of wrinkles ー
- Treatment of mild to moderate inflammatory acne vulgaris -
STATEMENT OF SUBSTANTIAL EQUIVALENCE
The LightWalker laser system family shares the same indications for use, similar design and functional features with, and therefore Fotona d.d. believes that its Light Walker laser system family is substantially equivalent to, the Fotona Fidelis III Er: YAG/Nd: YAG Laser System Family (K093162) previously cleared for incision, excision, vaporization, ablation and coagulation of soft and hard tissue in the mouth.
Details are provided in the Substantial Equivalence Discussion Section of this submission.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Fotona d.d. % Mr. Stojan Trost Quality Assurance and Regulatory Affairs Manager Stegne 7 1210 Ljubljana, Slovenia
NOV 22 26.
Re: K101817
Trade/Device Name: Fotana LightWalker Laser System Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 10, 2010 Received: November 12, 2010
Dear Mr. Trost:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 -- Mr. Stojan Trost
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
foe
DsO D.h
rk N. Melkerson
Mark N. Melk Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use Statement
510(k) Number (if known):
K1018/7
Device Name: Fotona LightWalker Laser System Family
NOV 2 2 2010
Indications For Use:
Er: YAG laser (2940 nm wavelength) in dentistry:
- Intra-oral soft tissue surgery (incision, excision, ablation coagulation) -
- Leukoplakia ﺴ
- Pulpotomy as adjunct to root canal retreatment -
- Pulp extirpation l
- Removal of fibromae -
- Removal of granulated tissue -
- Caries removal, cavity preparation, enamel roughening -
- Sulcular debridement -
- Tooth preparation to obtain access to 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 aa 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, 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; l
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 ﺖ
- Frenectomy and frenotomy -
- Gingival troughing for crown impressions -
Neil R.P. Osdem for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101817
1 2 // //
6
- Gingivectomy -
- Gingivoplasty -
- Gingival incision and excision -
- Hemostasis -
- Implant recovery -
- Incision and drainage of abscess -
- Laser assisted uvulopaletoplasty (LAUP) -
- Operculectomy -
- Oral papillectomies ー
- Pulpotomy and pulpotomy as an adjunct to root canal therapy -
- Reduction of denture hyperplasia ー
- 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 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 ー
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 -I hotoooogiaatein and marts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
- Treatment of wrinkles -
- Treatment of mild to moderate inflammatory acne vulgaris -
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)
Neil R.P. Ogden fir mxm
Concurrence of CDRH, Office of Device Evaluation(ensign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K, 601817