(90 days)
Not Found
Not Found
No
The device description focuses on the laser technology and hardware components, with no mention of AI or ML algorithms for image processing, data analysis, or treatment planning. The control system is described as selecting the laser source, not employing advanced computational techniques.
Yes
The device is described as a laser system intended for various surgical and dermatological treatments, including incision, ablation, vaporization, coagulation, and hemostasis of lesions and tissues across multiple anatomical sites. These applications are for the purpose of treating medical conditions, thus making it a therapeutic device.
No
The device is described as a laser system intended for surgical procedures such as incision, ablation, vaporization, coagulation, and hemostasis of various tissues and lesions. These are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a physical laser system with optical cavities, crystals, flashlamps, optical fiber delivery systems, articulated arms, power supply, control system, and cooling system. This is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for direct treatment of various tissues and lesions within the body. This involves physical interaction with the patient's tissues for incision, ablation, vaporization, coagulation, and hemostasis.
- Device Description: The device description details a laser system that delivers energy to the patient's tissues.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with patient specimens outside the body.
The device described is a therapeutic medical device, specifically a surgical laser system.
N/A
Intended Use / Indications for Use
The Fotona Dualis "KTP laser is intended for incision, ablation, vaporization, coacjulation, and hemostasis of vascular lesions and soft tissue in vanous surgical areas. 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. Dermatology : The treatment (hemostasis, color lightening, flattening, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
The Fotona Dualis Er:YAG laser is intended for surgical incision/excision, variorization and coaqulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, mucous membrane, lymplı vessels and nodes, organs and glands.
Dermatology an Plastic Surgery Indications: Epidermal nevi, telangiectasias, spider veins, actinic sheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing.
ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia Gynecology Indications: Herpes simplex, endomaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma.
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.
Oral/Maxillofacial Indications: Oral and glossal lesions and gingivectorny
Ophtalmology Indications: Soft tissue surrounding the eye and orbit and anterior capsulotomy Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae and matrixectomy Dentistry indications: Caries removal, cavity preparation, enamel etching
Product codes
GEX
Device Description
The Fotona Dualis " laser system is based on the Er: YAG (2940 nm) and KTP (532 nm) laser technology. It is modification to combine two lasers into one housing. The unmodified devices are the Fotona Fidelis Er:YAG laser and the Fotona Dualis " KTP laser system. There are two optical cavities containing the KTP and Er:Y.AG crystals, Both are activated by means of the use of flashlamps. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided:
- In case of the KTP laser through an optical fiber delivery system to a focusing . handpiece.
- . In case of the Er: Y AG laser through articulated arm to a focusing handpiece.
Both lasers share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Er.YAG laser source or the KTP laser source. When the laser is first turned on the physician is able to select the desired wavelength via control panel.
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, Epidermal nevi, telangiectasias, spider veins, actinic sheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing, ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia, Herpes simplex, endomaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma, internal organs, lesions, tissue, vessel, Oral and glossal lesions and gingivectorny, soft tissue surrounding the eye and orbit and anterior capsulotomy, Warts, plantar verrucae, large mosaic verrucae and matrixectomy, Caries, cavity, enamel
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.
Not Found
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
Appendix E : Summary of Safety and Effectiveness Data
| Company : | Fotona d.d.
Stegne 7, 1210 Ljubljana
SLOVENIA | NOV 2 5 2002 |
|-----------------------|-----------------------------------------------------------------|--------------|
| Contact Person : | Mojca Valjavec | |
| Preparation Date : | 08-12-02 | |
| Device Trade Names : | Fotona Dualis SV Er:YAG/KTP Laser System | |
| Common Name : | Combination of Long Pulse Er:YAG and KTP Lasers | |
| Classification Name : | Instrument, Surgical, Powered, Laser
79-GEX
21 CFR 878-48 | |
II. Description
I. General Information
The Fotona Dualis " laser system is based on the Er: YAG (2940 nm) and KTP (532 nm) laser technology. It is modification to combine two lasers into one housing. The unmodified devices are the Fotona Fidelis Er:YAG laser and the Fotona Dualis " KTP laser system. There are two optical cavities containing the KTP and Er:Y.AG crystals, Both are activated by means of the use of flashlamps. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided:
- In case of the KTP laser through an optical fiber delivery system to a focusing . handpiece.
- . In case of the Er: Y AG laser through articulated arm to a focusing handpiece.
Both lasers share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Er.YAG laser source or the KTP laser source. When the laser is first turned on the physician is able to select the desired wavelength via control panel.
III. Intended Use
The Fotona Dualis KTP laser is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas. 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.
1
The Fotona DualisSV Er:YAG laser is indicated for incision/excision, cutting, ablation, vaporization, and coagulation of soft and hard tissue in various surgical areas.
IV. Summary of Substantial Equivalence
Fotona believes that its Dualis" laser system is substantially equivalent to the Fotona DualisVP long pulse KTP laser system previously cleared for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, and to the Fotona Fidelis Er:YAG laser system previously cleared for incision/excision, cutting, ablation, vaporization, and coagulation of soft and hard tissue in various surgical areas.
They therefore have the same Intended Use as the Fotona Dualis " laser system.
The Dualiss Er: YAG/KTP laser system shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the predicate devices. The output characteristics are the same as those of the predicate devices.
The risk and benefits for the Dualis " laser system are comparable to the predicate devices when used for similar clinical applications.
It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of the Dualis" Er:YAG/KTP laser system.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 2002
Fotona D. D. Mojca Valjavec QA/RA Manager Stegne 7, 1210 Ljubljana Slovenia
Re: K022838
Trade/Device Name: Fotona DUALIS® Er: YAG/KTP Laser System Regulation Number: 878.4810 Regulation Name: Powered, laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: August 20, 2002 Received: August 27, 2002
Dear Sir or Madam:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); good manufacturing practice requirements as set forth in the
3
Page 2 - Sir or Madam .
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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix F : Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Fotona Dualis88 Er:YAG/KTP Laser System and Accessories
Indications For Use:
KTP Laser (532 nm)
The FotonA Dualis "KTP laser is intended for incision, ablation, vaporization, coacjulation, and hemostasis of vascular lesions and soft tissue in vanous surgical areas. 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. Dermatology :
The treatment (hemostasis, color lightening, flattening, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
Er:YAG Laser (2940 nm)
The Fotona Dualis Er:YAG laser is intended for surgical incision/excision, variorization and coaqulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, mucous membrane, lymplı vessels and nodes, organs and glands.
Dermatology an Plastic Surgery Indications: Epidermal nevi, telangiectasias, spider veins, actinic sheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing.
ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia Gynecology Indications: Herpes simplex, endomaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma.
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.
Oral/Maxillofacial Indications: Oral and glossal lesions and gingivectorny
Ophtalmology Indications: Soft tissue surrounding the eye and orbit and anterior capsulotomy Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae and matrixectomy Dentistry indications: Caries removal, cavity preparation, enamel etching
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF MEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Miriam C. Provost | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of General, Restorative and Neurological Devices | ||
| Prescription Use (Per 21 CFR 801.109) | ✓ 510(k) Number K022838 | Over-The-Counter Use |