(135 days)
Not Found
No
The device description focuses on the physical components and laser technology, with no mention of AI or ML capabilities for image processing, data analysis, or automated decision-making. The controller is described as microprocessor-based for regulating functions and parameter selection, which is standard for medical devices and does not imply AI/ML.
Yes
The device is described as a 'therapeutic' device in the "Device Description" section. Additionally, its intended uses, which include surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue for various medical specialties, are therapeutic in nature.
No
Explanation: The device is a laser system intended for surgical procedures such as incision, excision, ablation, vaporization, and coagulation of soft tissue. While it is indicated for "performing diagnostic biopsies" as one of its uses in dermatology, the device itself is a tool for the action of biopsy (tissue removal), not for the analysis or diagnosis of the collected tissue. Therefore, it is not a diagnostic device in the sense of providing a diagnosis from an output.
No
The device description clearly outlines a physical laser system with hardware components such as an optical cavity, flashlamps, articulated arm, and handpiece. While it includes a microprocessor-based controller, the core functionality and therapeutic effect are delivered through the laser hardware, not solely through software.
Based on the provided information, the Fotona Fidelis Er.YAG Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue." These are all procedures performed directly on the patient's body (in vivo).
- Device Description: The description details a laser system designed to deliver energy to tissue for surgical purposes. It does not describe any components or processes related to examining specimens outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Fotona Fidelis system's function is to surgically alter tissue, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Fotona Fidelis Er:YAG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, lymph vessels and nodes, organs, and glands
DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies.
General Surgery : surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated
Genitourinary : lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon
Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma
Oral Surgery : benign oral tumors, oral and glossal lesions and gingivottomy, gingivoplasty, frenectomy, sulcular debridement - removal of diseased or inflamed soft tissue in the periodontal pocket
Otorhinolaryngology(Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia
Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy
Podiatry : warts, plantar verrucae, large mosaic verrucae and matrixectomy
Product codes
GEX
Device Description
The Fotona Fidelis system is based on Er: YAG laser technology. Within the system, an optical cavity contains the Er: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in non-contact mode.
The System is capable of emitting up to 1.0 J of pulsed light at 2.94 um. This light has a pulsewidth which varies in the range 75 - 950 us. The laser is intended to be used for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
The Fidelis system is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.
c) An Er: Y AG laser rod, capable of generating 1.0 J optical pulses at a frequency up to 50 Hz.
d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
Accessories available for use with Fotona SkinPlus:
· Fotona SkinScan Scanning Device (K970757)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions.
General Surgery : soft tissue.
Genitourinary : lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon.
Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Oral Surgery : benign oral tumors, oral and glossal lesions and gingivottomy, gingivoplasty, frenectomy, sulcular debridement - removal of diseased or inflamed soft tissue in the periodontal pocket.
Otorhinolaryngology(Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy.
Podiatry : warts, plantar verrucae, large mosaic verrucae and matrixectomy.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Appendix E Summary of Safety and Effectiveness Data :
General Information and Description
g 1999 JUN
The Fotona Fidelis system is based on Er: YAG laser technology. Within the system, an optical cavity contains the Er: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in non-contact mode.
The System is capable of emitting up to 1.0 J of pulsed light at 2.94 um. This light has a pulsewidth which varies in the range 75 - 950 us. The laser is intended to be used for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
The Fidelis system is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.
c) An Er: Y AG laser rod, capable of generating 1.0 J optical pulses at a frequency up to 50 Hz.
d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
Accessories available for use with Fotona SkinPlus:
· Fotona SkinScan Scanning Device (K970757)
Summary of Substantial Equivalence
Fotona believes that its Fidelis system is substantially equivalent to the Laserscope Venus Erbium Laser System (EL Laser System) (K974896) and Laserscope Vela Erbium Laser System (K971843).
The Venus and Vela are cleared for surgical incision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. They therefore have the same Intended Use as the Fotona Fidelis.
1
Technologically, the predicate devices have identical characteristics to the Fidelis, all three comprising a flashlamp pumped Er: YAG laser rod generating light at a wavelength of 2.94 um, which is subsequently delivered to the patient via an articulated delivery arm and focusing handpiece.
The risk and benefits for the Fotona Fidelis are comparable to the Laserscope Venus and Vela when used for similar clinical applications.
The Laserscope Venus Erbium Laser System has the ability to deliver laser energy at 2.94 microns, maximum power of 20 watts at repetition rate of up to 20 Hz. These characteristics are very similar to the Fotona Fidelis Erbium Laser System.
It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 1999
Moica Valjavec, Dipl. Eng. Product Manager Laser Division Fotona d.d. Stegne 7, 1210 Ljubljana Slovenia
Re: K990243
Trade Name: Fotona Fidelis Er: YAG Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: April 26, 1999 Received: May 5, 1999
Dear Dr. Valjavec:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mojca Valjavec, Dipl. Eng.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
APPENDIX F
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K990743
Device Name:
FOTONA FIDELIS Er:YAG LASER SYSTEM
Indications For Use:
The Fotona Fidelis Er.YAG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, lymph vessels and nodes, organs, and glands
DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies.
General Surgery : surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated
Genitourinary : lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon
Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma
Oral Surgery : benign oral tumors, oral and glossal lesions and gingivottomy, gingivoplasty, frenectomy, sulcular debridement - removal of diseased or inflamed soft tissue in the periodontal pocket ﺷﻬﺮ
Otorhinolaryngology(Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia
Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy
Podiatry : warts, plantar verrucae, large mosaic verrucae and matrixectomy
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990243 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use |