(90 days)
Not Found
No
The summary describes a laser system based on Nd:YAG technology and its optical components. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is indicated for medical applications such as coagulation and hemostasis of vascular lesions, and incision/excision of soft body tissue, which are therapeutic interventions.
No
The device description and intended use indicate it is an Nd:YAG laser system for surgical and aesthetic applications, such as hair reduction, removal of unwanted hair, coagulation, hemostasis, and incision/excision of soft tissue. These are therapeutic and interventional applications, not diagnostic ones.
No
The device description clearly describes a laser system with physical components like an optical cavity, crystal, flashlamps, beamsplitter, optical fiber, and handpiece. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Fotona DUALIS'" Plus Nd: YAG laser system clearly indicate that it is a surgical and aesthetic laser system used for direct treatment of soft tissue on the body. It is used for procedures like hair reduction, vascular lesion treatment, and tissue incision/excision.
- Lack of In Vitro Testing: There is no mention of the device being used to analyze samples taken from the body. Its function is to directly interact with the body's tissues.
Therefore, the Fotona DUALIS'" Plus Nd: YAG laser system falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fotona DUALIS Plus Nd: YAG laser system 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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Fotona DUALIS 8 Plus system is based on the Nd: Y AG laser technology. Within the system, an optical cavity contains the Nd: Y AG 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 beams 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 (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.
Altus Medical Aesthetic Nd:YAG Laser (K022839 is the subject device)
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
839 Appendix E:
1/2 Summary of Safety and Effectiveness Data
I. General Information
NOV 2 5 2002
| Company : | Fotona d.d.
Stegne 7, 1210 Ljubljana
SLOVENIA |
|-----------------------|-----------------------------------------------------------------|
| Contact Person : | Mojca Valjavec |
| Preparation Date : | 08-05-01 |
| Device Trade Names : | Fotona DUALISXP Plus Nd:YAG Laser Systern |
| Common Name : | Nd:YAG Pulsed Surgical Laser System |
| Classification Name : | Instrument, Surgical, Powered, Laser
79-GEX
21 CFR 878-48 |
II. Description
The Fotona DUALIS 8 Plus system is based on the Nd: Y AG laser technology. Within the system, an optical cavity contains the Nd: Y AG 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 beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.
II. Intended Use
The Fotona DUALIS* Plus Nd: YAG laser system 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 system 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 Fotona DUALIS'x Plus laser shares the same general indications for use, and therefore is substantially equivalent to the currently marketed Altus Medical Aesthetic Nd:YAG Laser.
510(k) Submission: The Fotona DUALISNº Plus Nd:YAG Laser System
1
K022839 2/2 Technologically, the predicate device has similar characteristics to the DUALISM Plus laser. Both 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.
Both lasers utilize class I aiming beams which pose no hazard to the user.
Both systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection and avoids hazard incidence
Both 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*P Plus laser system are comparable to the predicate device 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* Plus laser system.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 200 Corporate Boulevard ockville MD 20850
NOV 2 5 2002
Fotona D. D. Mojca Valjavec OA/RA Manager . Stegne7, 1210 Ljubljana Slovenia
Re: K022839
Trade/Device Name: Fotona DUALIS Plus Nd: YAG Laser System Regulation Number: 878.4810 Regulation Name: Instrument, powered surgical laser 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 yours,
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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K (222 3 9
Device Name:
Fotona DUALISNY Plus Nd: YAG Laser System and Accessories
Indications For Use:
The Fotona DUALIS'" Plus Nd: YAG laser system 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
iriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number: KC22839
510(k) Submission: The Fotona DUALISM Plus Nd:YAG Laser System