(99 days)
Not Found
No
The device description focuses on traditional laser technology and control systems, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is used for medical procedures such as the removal of tattoos, pigmented lesions, and hair, and for skin resurfacing, all of which are considered therapeutic applications.
No
The device description and intended use indicate that the Fotona QX laser system is used for various therapeutic treatments such as tattoo removal, lesion removal, and skin resurfacing, not for diagnosing conditions.
No
The device description clearly outlines significant hardware components including a laser head, power supply, cooling system, optical delivery system, and handpiece. While it mentions a microprocessor-based controller, the core functionality and therapeutic action are delivered through physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Fotona QX laser system is a therapeutic device that uses laser energy to directly treat soft tissue, skin, tattoos, and hair on the patient's body. It is used for procedures like incision, excision, ablation, and vaporization.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device interacts directly with the patient's tissue.
Therefore, the intended use and device description clearly indicate that this is a therapeutic device used for direct treatment, not an in vitro diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Nd:YAG (1064 nm) laser is capable of delivering up to 1.0 J of laser energy. Its The Nd. ITAS (100+ mir) tabel 16 capaces on or sizes available range from 2 to 8 mm. This nominal pulsewithin is 1 7 minoooooonaed for incision/excision, ablation, vaporization of soft tissue in general dermatology, removal of dark ink (black, blue and brown) tattoos, Son lissue in general definatorial or lightening of unwanted hair, treatment of Common Nevi.
The frequency doubled Nd: YAG (532 nm) KTP laser delivers up to 0.5J of laser energy in 4-9 nanosecond pulses. Spot sizes available range from 2 to 7 mm. This laser wavelength is intended to be used for incision/excision, ablation, vaporization of soft wavelength is intended to be assureal of light ink (red, tan, purple, and orange) tatoos, removal of pigmented lesions, removal of vascular lesions, treatment of Lentigines, treatment of Cafe-Au-Lait, treatment of Common Nevi, treatment of Seborrheic Kearotoses, and treatment of Post Inflammatory Hyperpigmentation.
Indications For Use:
-
- Incision, excision, ablation, vaporization of soft tissue for general dermatology.
-
- 532 nm wavelength:
- removal of light ink (red, tan, purple, and orange) tatoos, "
- removal of pigmented lesions, removal of vascular lesions,
- treatment of Lentigines, treatment of Cafe-Au-Lait,
- treatment of Common Nevi,
- treatment of Seborrheic Kearotoses,
- treatment of Post Inflammatory Hyperpigmentation.
-
- 1064 nm wavelength:
- removal of dark ink (black, blue and brown) tattoos, -
- treatment of Nevus of Ota, -
- removal or lightening of unwanted hair, -
- treatment of Common Nevi. -
- skin resurfacing with or without adjuvant preparation --
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Fotona QX laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd: YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser 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 by articulated arm to a focusing handpiece. Both lasers are used in non-contact mode.
Both laser wavelengths share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Nd: YAG head or the KTP Nd: YAG laser wavelength. When the laser is first turned on the physician is able to select the desired wavelength via control panel.
The Fotona QX laser system consists of:
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) The microprocessor based controller, which regulates the functions of both lasers and allows parameter selection by the user.
d) The Nd: YAG laser head.
e) The frequency doubling crystal.
g) The optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Appendix E : Summary of Safety and Effectiveness Data
| I. General Information | FEB 1 6 2006 | K053139 |
|---|---|---|
| Company : | Fotona d.d. | |
| Stegne 7, 1210 Ljubljana | ||
| SLOVENIA | ||
| Contact Person : | Stojan Trošt | |
| Preparation Date : | 11-04-05 | |
| Device Trade Names : | Fotona QX Nd:YAG/KTP Laser System | |
| Common Name : | Combination of Q-switched Nd:YAG and KTP Nd:YAG Lasers | |
| Classification Name : | Instrument, Surgical, Powered, Laser | |
| 79-GEX | ||
| 21 CFR 878-48 |
II. Description
The Fotona QX laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd: YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser 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 by articulated arm to a focusing handpiece. Both lasers are used in non-contact mode.
Both laser wavelengths share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Nd: YAG head or the KTP Nd: YAG laser wavelength. When the laser is first turned on the physician is able to select the desired wavelength via control panel.
The Fotona QX laser system consists of:
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) The microprocessor based controller, which regulates the functions of both lasers and allows parameter selection by the user.
d) The Nd: YAG laser head.
1
e) The frequency doubling crystal.
g) The optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.
III. Intended Use
The Nd:YAG (1064 nm) laser is capable of delivering up to 1.0 J of laser energy. Its The Nd. ITAS (100+ mir) tabel 16 capaces on or sizes available range from 2 to 8 mm. This nominal pulsewithin is 1 7 minoooooonaed for incision/excision, ablation, vaporization of soft tissue in general dermatology, removal of dark ink (black, blue and brown) tattoos, Son lissue in general definatorial or lightening of unwanted hair, treatment of Common Nevi.
The frequency doubled Nd: YAG (532 nm) KTP laser delivers up to 0.5J of laser energy in 4-9 nanosecond pulses. Spot sizes available range from 2 to 7 mm. This laser wavelength is intended to be used for incision/excision, ablation, vaporization of soft wavelength is intended to be assureal of light ink (red, tan, purple, and orange) tatoos, removal of pigmented lesions, removal of vascular lesions, treatment of Lentigines, treatment of Cafe-Au-Lait, treatment of Common Nevi, treatment of Seborrheic Kearotoses, and treatment of Post Inflammatory Hyperpigmentation.
IV. Summary of Substantial Equivalence
Fotona believes that its Fotona QX laser system is substantially equivalent to the
a) Spectra -VRM Q-switched Nd: YAG Laser System (K000317) previously cleared for:
- Incision, excision, ablation, vaporization of soft tissue for general dermatology
- 532 nm wavelength:
- removal of light ink (red, tan, purple, and orange) tatoos,
- removal of pigmented lesions, removal of vascular lesions,
- treatment of Lentigines, treatment of Cafe-Au-Lait,
- treatment of Common Nevi, ।
- treatment of Seborrheic Kearotoses, ।
- treatment of Post Inflammatory Hyperpigmentation. ।
- 1064 nm wavelength: =
- removal of dark ink (black, blue and brown) tattoos, -
- treatment of Nevus of Ota, -
- removal or lightening of unwanted hair, -
- treatment of Common Nevi. -
b) Medlite C6 Q-Switched Nd:YAG Laser (K 014234) previously cleared for incision, excision, ablation, vaporization of soft tissue for general dermatology, Tatoo removal, treatment of Vascular Lesions and treatment of Pigmented Lesions.
c) Palomar Q-YAG Nd:YAG Laser System (K023967) previously cleared for skin resurfacing with or without adjuvant preparation at the 1064 nm wavelength.
510(k) Submission: Fotona QX Nd: YAG/KTP Laser System
2
They therefore have the same Intended Use as the Fotona QX laser system.
The Fotona QX laser system shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the medicate devices. The output characteristics are the same as those of the predicate devices.
The risk and benefits for the Fotona QX 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 Fotona QX Nd: YAG/KTP laser system.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its head, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
FEB 1 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stojan Trost Manager Quality Assurance & Regulatory Affairs Fotona D.D. Stegne 7 1210 Ljubljana SLOVENIA
Re: K053139
Trade/Device Name: Fotona QX Nd: Y AG/KTP Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: 21 CFR 078.1070
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 5, 2006 Received: January 9, 2006
Dear Mr. Trost:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) premained is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosule) it regars and the Medical Device Amendments, or to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that Go not require appen o the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the line, 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 it may of Subject to Saon additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of eneming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuance or a cassince complies with other requirements of the Act that I DA has made a decertimation administered by other Federal agencies. You must of any I cocraf statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - Mr. Kahan
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (2001) 100 (2006) (2006) 1985 (2006) 1985-1994 (21 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the support of any and consumeration of your device to a legal This letter will allow you to begin marketing your avvalence of your device to a legally
premarket notification. The FDA finding of substantial end the permits vour premarket notification. The FDA Inding of basisance of the results 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
rs the latest of the support of 115 - All and assesses the regulation entit If you desire specific advice for your device on our an Also, please note the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the r contact the Office of Compliance at (240) 270 - 121 - 121 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by reference to prematici notification (c) * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * other general information on your responsionities and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at to vote a
(301) 443-6597 or at its Internet address http://www.fda.cov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Appendix F : Indications for Use Statement
510(k) Number (if known): K053139
Device Name: Fotona QX Nd:YAG/KTP Laser System
Indications For Use:
-
- Incision, excision, ablation, vaporization of soft tissue for general dermatology.
-
- 532 nm wavelength:
- removal of light ink (red, tan, purple, and orange) tatoos, "
- removal of pigmented lesions, removal of vascular lesions,
- treatment of Lentigines, treatment of Cafe-Au-Lait,
- treatment of Common Nevi,
- treatment of Seborrheic Kearotoses,
- treatment of Post Inflammatory Hyperpigmentation.
-
- 1064 nm wavelength:
- removal of dark ink (black, blue and brown) tattoos, -
- treatment of Nevus of Ota, -
- removal or lightening of unwanted hair, -
- treatment of Common Nevi. -
- skin resurfacing with or without adjuvant preparation --
(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)
ØR
(Division Sig
Division of General, Restorative,
and Neurolog Devices
510(k) Number
Over-The-Counter Use
510(k) Submission: Fotona QX Nd:YAG/KTP Laser System