(308 days)
Not Found
No
The document describes a laser system and handpieces for dermatological and general surgery procedures. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is based on traditional laser physics and control systems.
Yes
The device is intended for dermatological procedures requiring resurfacing of soft tissue and general surgery applications involving surgical incision, vaporization, and coagulation of soft tissue, which are therapeutic interventions.
No
The device is described as a laser system intended for dermatological procedures requiring resurfacing of soft tissue, as well as general surgery applications for incision, vaporization, and coagulation of soft tissue. These are therapeutic and surgical functions, not diagnostic ones.
No
The device description clearly outlines physical hardware components including a laser source, power supply, cooling unit, electronics, footswitch, articulated arm, and handpieces. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's soft tissue (resurfacing, incision, vaporization, coagulation, excision, ablation). IVDs are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The description details a laser system that delivers energy to the patient's tissue. This is a therapeutic or surgical device, not a diagnostic one that analyzes biological samples.
- Anatomical Site: The anatomical site is "Soft tissue," which refers to the patient's body, not a sample taken from the body.
The device is a laser system used for surgical and dermatological procedures, which falls under the category of therapeutic or surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Fotona F-22 Handpiece is intended for:
- In fractionated mode: -
- Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
- In non-fractionated mode: ।
- General Surgery Indications: Surgical incision, 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 is necessary;
The Fotona FS-01 Handpiece is intended for:
- Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.
Product codes (comma separated list FDA assigned to the subject device)
ONG, GEX
Device Description
The F-22 Handpiece and FS-01 Handpiece each attach to the Dynamis Er: Y AG/Nd: YAG Laser Systems. The Fotona Dynamis Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The F-22 handpiece and FS-01 handpiece are designed to be used with the Er:YAG (2940 nm) laser wavelength only. The laser system console consists of a flashlamp pumped Er: YAG laser source, power supply, water colling unit, electronics, and a footswitch. Electrical power is supplied to the console by the facility's power source. A red diode aiming beam (650 nm) is combined with the therapeutic Er:YAG laser beam. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er:YAG laser). Fotona's power supply and electronics, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing:
A clinical and histological study with the Fotona Dynamis SP laser system (a model from The Fotona Dynamis Er:YAG/Nd:YAG Laser System Family) using FS-01 stamping fractionated handpiece and F22 scanning fractionated handpiece has been performed to demonstrate the benefits of dermatological procedures requiring resurfacing and ablation of soft tissue with the fractionated handpieces.
Non-clinical performance testing
Fotona F-22 Laser Handpiece (F-Runner) and Fotona FS-01 Laser Handpieces are designed. tested and will be manufactured in accordance with both mandatory and voluntary standards including:
- 21 CFR 1040.10 Performance Standards for Light Emitting Products, Laser products .
- 21 CFR 1040.11 Performance Standards for Light Emitting Products, Specific . purpose laser products
- IEC 60601-1 Ed.3.0: 2005 + Corr 1. 2006 + Corr 2. 2007 Medical electrical . equipment. Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Ed.3.0: 2007 Medical electrical equipment. Part 1-2: General . requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-4 Ed. 1.1: 1996 + A1:1999 Medical electrical equipment. Part 1-4: . Collateral standard: Programmable electric medical systems.
- IEC 60601-1-6 Ed.2.0:2007 Medical electrical equipment: Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability
- . IEC 60601-2-22 Ed. 2.0: 1996 - Medical electrical equipment, Part 2: Particular requirements for safety diagnostic and therapeutic laser equipment.
- IEC 60825-1 Ed. 2.0 /2007 Safety of laser products. Part 1: Equipment classification . and requirements.
- EN 62304: 2006 Medical device Software software life-cycle process .
- ISO 17664:2004 Sterilization of medical devices Information to be provided by the . manufacturer for the processing of resterilizable medical devices
Laboratory testing was conducted to validate and verify that the proposed handpieces: Fotona F-22 Laser Handpiece (F-Runner) and Fotona FS-01 Laser Handpieces met all design specifications and was substantially equivalent to the predicate devices.
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
5. 510(k) Summary
1. SUBMITTER'S INFORMATION
Name:
Fotona d.d.
Address:
Stegne 7 1000 Ljubljana, Slovenia Phone: +386 15009100 Fax: + 386 5009 200
Contact Person:
Stojan Trošt, QA&RA Manager Phone: + 386 1 5009 299 E-mail: stojan.trost@fotona.com
Date Prepared: July 8, 2014
2. DEVICE INFORMATION
| Trade Name: | Fotona F-22 Laser Handpiece (F-Runner), |
|---|---|
| Fotona FS-01 Laser Handpiece |
Common Name: Er:YAG Surgical Laser
Classification Name: Powered laser surgical instrument with microbeam\fractional output
Product Code: ONG, GEX
3. PREDICATE DEVICES
Fotona Dynamis Er:YAG/Nd:YAG Laser System Family (K101306),
JOULE Multi-Platform System (K101916),
Dermablate Effect, ASCLEPION Laser Technologies GmbH (K081541)
JUL 1 1 2014 K1328DL
1
4. DEVICE DESCRIPTION
The F-22 Handpiece and FS-01 Handpiece each attach to the Dynamis Er: Y AG/Nd: YAG Laser Systems. The Fotona Dynamis Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The F-22 handpiece and FS-01 handpiece are designed to be used with the Er:YAG (2940 nm) laser wavelength only. The laser system console consists of a flashlamp pumped Er: YAG laser source, power supply, water colling unit, electronics, and a footswitch. Electrical power is supplied to the console by the facility's power source. A red diode aiming beam (650 nm) is combined with the therapeutic Er:YAG laser beam. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er:YAG laser). Fotona's power supply and electronics, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch.
4. INTENDED USE
The Fotona F-22 Handpiece is intended for:
- In fractionated mode: -
- Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
- In non-fractionated mode: ।
- General Surgery Indications: Surgical incision, 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 is necessary;
The Fotona FS-01 Handpiece is intended for:
- Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.
5. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The F-22 Handpiece and FS-01 Handpiece accessories to Fotona Dynamis family have the same technological and design characteristics (design, chemical composition, energy source: wavelength, active medium, cooling system, power supply, beam delivery, controls, housine) as the previously cleared devices. The output characteristics are for the intended use the same as those of the predicate devices. The risk and benefits for the F-22 Handpiece and FS-01 Handpiece accessories to Fotona Dynamis Fotona Dynamis Laser System family are identical to the predicate devices when used for similar clinical applications.
2
| Er: YAG
2940 nm | Sciton JOULE Multi-
Platform System Er:YAG
(K101916) | Fotona Dynamis Laser
System Family
(K101306) | Dermablate Effect,
ASCLEPION Laser
Technologies GmbH
(K081541) | Fotona Dynamis Laser
System Family
(new submission) |
|--------------------|------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------|
| Wavelength | 2940 mm | 2940 nm | 2940 nm | 2940 nm |
| Laser media | Flashlamp pumped solid
state
rod | Flashlamp pumped solid
state
rod | Flashlamp pumped solid
state
rod | Flashlamp pumped solid
state
rod |
| Aiming beam | 630 - 680 nm | 650 nm | 650 nm | 650 nm |
| Output mode | Pulsed | Pulsed | Pulsed | Pulsed |
| Pulse energy | 20-8000 mJ | 30 - 3000 mJ | Up to 1500 mJ | 30 - 3000 mJ |
| Pulsewidth | 100 - 500 us | 100 - 1500 us | 400 us | 100 - 300 us |
| Repetition rate | Up to 40 Hz | up to 50 Hz | Up to 20 Hz | up 10 50 Hz |
| Power | 40W | up to 20 W | Up to 12W | up to 20 W |
| Beam Delivery | Articulated arm | Articulated arm | Articulated arm | Articulated arm |
| User interface | LCD Touchscreen | Push button control | LCD Touchscreen | Push button control |
| Handpieces | ProFractional | R08 | Asclepion Dermablate
Effect with MicroSpot
handpiece | FS-01
F22 |
Figurl : Comparison table of the technical characteristics for the predicate laser system and for the host laser system for the newly submitted handpieces
6. STATEMENT OF SUBSTANTIAL EQUIVALENCE
The F-22 Handpiece and FS-01 Handpiece are substantially equivalent in terms of indications for use and technology based on technical characteristics to the following predicate devices when used according to its intended use: Fotona Dynamis Er.YAG/Nd:YAG Laser System Family (K101306) and JOULE Multi-Platform System with Profractional handpiece (K101916), Dermablate Effect, ASCLEPION Laser Technologies GmbH (K081541).
7. TESTING
Clinical testing:
A clinical and histological study with the Fotona Dynamis SP laser system (a model from The Fotona Dynamis Er:YAG/Nd:YAG Laser System Family) using FS-01 stamping fractionated handpiece and F22 scanning fractionated handpiece has been performed to demonstrate the benefits of dermatological procedures requiring resurfacing and ablation of soft tissue with the fractionated handpieces.
3
Non-clinical performance testing
Fotona F-22 Laser Handpiece (F-Runner) and Fotona FS-01 Laser Handpieces are designed. tested and will be manufactured in accordance with both mandatory and voluntary standards including:
- 21 CFR 1040.10 Performance Standards for Light Emitting Products, Laser products .
- 21 CFR 1040.11 Performance Standards for Light Emitting Products, Specific . purpose laser products
- IEC 60601-1 Ed.3.0: 2005 + Corr 1. 2006 + Corr 2. 2007 Medical electrical . equipment. Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Ed.3.0: 2007 Medical electrical equipment. Part 1-2: General . requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-4 Ed. 1.1: 1996 + A1:1999 Medical electrical equipment. Part 1-4: . Collateral standard: Programmable electric medical systems.
- IEC 60601-1-6 Ed.2.0:2007 Medical electrical equipment: Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability
- . IEC 60601-2-22 Ed. 2.0: 1996 - Medical electrical equipment, Part 2: Particular requirements for safety diagnostic and therapeutic laser equipment.
- IEC 60825-1 Ed. 2.0 /2007 Safety of laser products. Part 1: Equipment classification . and requirements.
- EN 62304: 2006 Medical device Software software life-cycle process .
- ISO 17664:2004 Sterilization of medical devices Information to be provided by the . manufacturer for the processing of resterilizable medical devices
Laboratory testing was conducted to validate and verify that the proposed handpieces: Fotona F-22 Laser Handpiece (F-Runner) and Fotona FS-01 Laser Handpieces met all design specifications and was substantially equivalent to the predicate devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2014
Fotona d.d. Stojan Trost Quality Assurance & Regulatory Affairs Manager Stegne 7, 1000 Ljubljana, Slovenia
Re: K132806 Trade/Device Name: Fotona F-22 Laser Hand piece (F-Runner), Fotona FS-01 Laser Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONG, GEX Dated: June 12, 2014 Received: June 16, 2014
Dear Stojan Trost:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
5
Page 2 - Stojan Trost
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No, 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132806
Device Name
Fotona F-22 (f-runner), Fotona FS-0) laser handpieces
Indications for Use (Describe)
The Fotona F-22 Handpiece is intended for:
. In fractionated mode:
Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
: ` In non-fractionated mode:
General Surgery Indications: Surgical incision, 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 is necessary;
The Fotona FS-01 Handpiece is intended for:
Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.07.10 16:45:17 -04'00'
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