(87 days)
Not Found
No
The device description and intended use focus solely on the laser technology and its applications, with no mention of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is indicated for surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, including hair reduction, removal of unwanted hair, coagulation and hemostasis of vascular lesions, and incision/excision of soft body tissue, which are all therapeutic uses.
No
The device description and intended use indicate that the Fotona DUALIS Nd:YAG laser systems are used for surgical and aesthetic applications (e.g., hair reduction, coagulation, incision/excision, tissue ablation), which are therapeutic and procedural, not diagnostic.
No
The device description clearly outlines hardware components such as an optical cavity, Nd: YAG crystal, flashlamps, beamsplitter assembly, optical fiber delivery system, and a focusing handpiece. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing happens outside the body (in vitro).
- Device Function: The Fotona DUALIS Nd:YAG laser system is used for surgical and aesthetic applications that involve directly interacting with soft tissue on the body (in vivo). It uses laser energy to target chromophores for procedures like hair reduction, vascular lesion treatment, and tissue incision/excision.
The intended use and device description clearly indicate that this is a therapeutic and surgical device, not a diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The family of Fotona DUALIS Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition, the family is indicated to effect stable long-term, or permanent hair reduction in Fitzpatrick skin types I - VI through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long-term stable reduction in number of hairs regrowing after a treatment regimen).
The family of Fotona DUALIS Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:
- To effect stable long-term, or permanent, hair reduction in skin types I VI through . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen.
- For removal of unwanted hair. ◆
- For coagulation and hemostasis of vascular lesions.
- For incision/excision of soft body tissue in dermatology .
- For soft tissue general surgery applications skin incision, tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation
Product codes
GEX
Device Description
The family of Fotona Dualis systems is based on the Nd: YAG laser technology. Within the systems, an optical cavity contains the Nd: 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 therapeutic and aiming bearns are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Not Found
Key Metrics
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
DEC 0 6 2001 ppendix E:
Summary of Safety and Effectiveness Data
- I. General Information
K013047
| Company : | Fotona d.d.
Stegne 7, 1210 Ljubljana
SLOVENIA |
|-----------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Mojca Valjavec |
| Preparation Date : | 05-09-01 |
| Device Trade Names : | Fotona DualisXP Nd:YAG Laser System
Fotona DualisVP Nd:YAG Laser System
Fotona Twinlight Nd:YAG Laser System |
| Common Name : | Nd:YAG Pulsed Surgical Laser System |
| Classification Name : | Instrument, Surgical, Powered, Laser
79-GEX
21 CFR 878-48 |
II. Description
The family of Fotona Dualis systems is based on the Nd: YAG laser technology. Within the systems, an optical cavity contains the Nd: 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 therapeutic and aiming bearns are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.
II. Intended Use
The family of Fotona DUALIS Nd: YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition, the family is indicated to effect stable long-term, or permanent hair reduction in Fitzpatrick skin types I - VI through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long-term stable reduction in number of hairs regrowing after a treatment regimen).
III. Summary of Substantial Equivalence
The family of Fotona DUALIS lasers shares the same general indications for use, and therefore is substantially equivalent to the currently marketed Laserscope Lyra (K010834) and to Altus Medical Aesthetic Nd: YAG Laser (K003202).
1
Technologically, the predicate devices have similar characteristics to the DUALIS lasers. All systems comprising a flashlamp pumped Nd. YAG laser rod generating light at a wavelength of 1064 nm, which is subsequently delivered to the patient via an optical fiber delivery system and focusing handpiece.
All lasers utilize class I aiming beams which pose no hazard to the user.
All systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection and avoids hazard incidence.
All systems utilize an internal closed loop water-air heat exchanger circuit for optimal thermal control of the laser cavity.
The risk and benefits for the DUALIS family 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 family.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The logo is simple and conveys a sense of national authority and health-related services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Mojca Valjavec, Dipl. Eng. Laser Division Fotona d.d. Stegne 7 1210 Ljubljana Slovenia
Re: K013047
Trade Name: Fotona DUALIS Nd: YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: September 6, 2001 Received: September 10, 2001
Dear Ms. Valjavec:
We have reviewed your Section 510(k) premarket 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 May 20, 1970, and charter 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, (Trefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer and act include requirements for annual registration, listing of devices, Controls provisions or are ice, 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 If your device 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 or any 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 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.
3
Page 2 – Ms. Mojca Valjavec
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours over finding of substantial equivalence of your device to a legally premarket notifications of 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 11 you desire specific advise for in vitro diagnostic devices), please contact the Office of additionally 21 Cl 1 1 1 1 1 1 1 4 659. Additionally, for questions on the promotion and advertising of Compination at (301) 69 to 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 Other general mistmational 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 yours,
Susan Walker
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX F
Page I of 1
INDICATIONS FOR USE STATEMENT
KO13047 510(k) Number (if known):
Device Name:
Family of Fotona DUALIS Nd:YAG Laser Systems and Accessories
Indications For Use:
The family of Fotona DUALIS Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:
- To effect stable long-term, or permanent, hair reduction in skin types I VI through . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen.
- For removal of unwanted hair. ◆
- For coagulation and hemostasis of vascular lesions.
- For incision/excision of soft body tissue in dermatology .
- For soft tissue general surgery applications skin incision, tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Susan Walker, m
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KO13047
510(k) Submission: Family of Fotona DUALIS Nd: YAG Lasers