(280 days)
No
The summary describes a laser system with a control system, but there is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications. The operation is stated to be completely under physician control.
Yes
The device is clearly indicated for surgical procedures in various medical specialties, including ophthalmology, which are therapeutic in nature. The "Summary of Performance Studies" also explicitly refers to it as "surgical, cosmetic, therapeutic and diagnostic laser equipment".
No
Explanation: The device description states its purpose is for "vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue," which are surgical/treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a "Lite Touch™ Er:YAG Laser Treatment System" and details hardware components such as a cabinet containing the laser source, control system, power supply, internal cooling system, articulated arm, and hand piece.
Based on the provided information, the Lite Touch™ Er YAG Laser Treatment System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue" in various surgical specialties. This describes a direct surgical intervention on living tissue within the body.
- Device Description: The description details a laser system that delivers a beam to the body for surgical procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Lite Touch™ does not perform any such analysis of specimens.
Therefore, the Lite Touch™ is a surgical laser device, not an IVD.
N/A
Intended Use / Indications for Use
Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:
- · Dermatology
- · Cosmetic surgery
- · Plastic and general surgery
- · Oral surgery
- · Gynecology
- · Otorhinolaryngology
- · Podiatry
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Gynecology; Otorhinolaryngology; and Podiatry.
The Lite Touch™ was previously cleared under K974460 in October 1997. This submission contains an expansion of the previously cleared indications for use. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.
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)
The Lite Touch TM device for this 510(k) submission is fundamentally unchanged from the device that was cleared under K974460. The Lite Touch TM is in compliance with the requirements of 21 CFR 1040.10 -Performance Standards for light-Emitting Products, and with 21 CFR 1040.11 - Performance Standards for Light-Emitting Products, Specific purpose laser products. The device has been tested for conformance to IEC 60601-1 Ed.3.0: 2005 + Corr 1. 2006 + Corr 2. 2007: EN 60601-1 :2006/AC: 2010 Medical electrical equ1pment. Part 1 General requirements for basic safety and essential performance, IEC 60601-1-2 2007, EN 60601-1-2: 2007; EN 60601-1-2 2007/AC 2010 Medical electrical equipment. Part 1-2 General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility -Requirements and tests; IEC 60601-2-22 2007, EN 60601-2-22 2013 Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment; I EC 60825-1: 2007. EN 60825-1: 2007 Safety of laser products. Part 1: Equipment classification and requirements: IEC 62366: 2007/ A 1 :2014; EN 62366: 2008 Medical devices-Application of usability engineering to medical devices, and with IEC 60601-1-6: 2010: EN 60601-1-6: 2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance-Collateral standard: Usability.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three wave-like lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2016
Focus Medical LLC Mr. John Lee Owner 23 Francis J. Clarke Circle Bethel, Connecticut 06801
Re: K152737
Trade/Device Name: Lite Touch 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: GEX Dated: May 5, 2016 Received: May 23, 2016
Dear Mr. Lee:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/8 description: The image shows the name "Jennifer R. Stevenson -A" in a large, bold font. The text is black and is set against a white background. In the background, there is a faint, gray watermark of the FDA logo.
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
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Indications for Use
510(k) Number (if known) K152737
Device Name
Lite Touch™ Er YAG Laser Treatment System
Indications for Use (Describe)
Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:
- · Dermatology
- · Cosmetic surgery
- · Plastic and general surgery
- · Oral surgery
- · Gynecology
- · Otorhinolaryngology
- · Podiatry
Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary (21 CFR 807.92c)
| Submitter: | Focus Medical |
|---|---|
| Address: | 23 Frances J. Clarke Circle |
| Bethel, CT, USA | |
| 06801 | |
| Phone: | 203-730-8885 |
| Fax: | 203-730-8851 |
| Date Prepared: | 11 January 2016 |
| Name of Submission Device: | Lite Touch™, previously cleared under K974460 |
| Trade or Proprietary Name: | Lite Touch™ |
| Common/Usual Name: | Lite Touch™ Er:YAG Laser Treatment System |
| Classification: | Class II |
| Regulation: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Classification Name: | Powered Laser Surgical Instrument |
| Review Panel: | General and Plastic Surgery |
| Predicate Device: | Asceplion MCL 31 Dermablate (K150140) |
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Device Description:
The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Gynecology; Otorhinolaryngology; and Podiatry.
The Lite Touch™ was previously cleared under K974460 in October 1997. This submission contains an expansion of the previously cleared indications for use. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.
Indications for Use:
Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, incision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:
- . Dermatology
- Cosmetic surgery ●
- Plastic and general surgery
- . Oral surgerv
- . Gynecology
- Otorhinolaryngology
- Podiatry
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Technological Characteristics:
| Performance Characteristic | Lite Touch™ | MCL 31 Dermablate |
|---|---|---|
| 510K | Not assigned | K150140 |
| Manufacturer | Focus Medical LLC | Asclepion Laser Technologies |
| Power | 24w | 20w |
| Energy (pulse and super pulse) | 35-3000 mJ | 2500mj max |
| Length of Pulse | 300-1000us | 100-1000us |
| Frequency of Pulse | Up to 16 Hz | 20 Hz |
| Spot size at target | 4, 6, 8, 10 mm | 1 – 12mm |
| Wavelength | 2940 nm | 2940 nm |
| Output mode | Pulsed | Pulsed |
| Beam delivery | Articulated Arm | Articulated Arm |
| Aiming Beam | 635 nm | 650nm |
| Laser medium | Flashlamp pumped solid state Er:YAG rod | Flashlamp pumped solid state Er:YAG rod |
| Cooling methods | Water/air heat exchanger | Water/air heat exchanger |
| Display/User Interface | Graphic user interface touchscreen | Graphic user interface touchscreen |
| Power calibration | Internal | Internal |
The subject and predicate device K150140 use similar technology, and differences between the subject and predicate device do not raise any new types of questions regarding safety or effectiveness for the subject device's intended use.
Testing Performance:
The Lite Touch TM device for this 510(k) submission is fundamentally unchanged from the device that was cleared under K974460. The Lite Touch TM is in compliance with the requirements of 21 CFR 1040.10 -Performance Standards for light-Emitting Products, and with 21 CFR 1040.11 - Performance Standards for Light-Emitting Products, Specific purpose laser products. The device has been tested for conformance to IEC 60601-1 Ed.3.0: 2005 + Corr 1. 2006 + Corr 2. 2007: EN 60601-1 :2006/AC: 2010 Medical electrical equ1pment. Part 1 General requirements for basic safety and essential performance, IEC 60601-1-2 2007, EN 60601-1-2: 2007; EN 60601-1-2 2007/AC 2010 Medical electrical equipment. Part 1-2 General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility -Requirements and tests; IEC 60601-2-22 2007, EN 60601-2-22 2013 Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment; I EC 60825-1: 2007. EN 60825-1: 2007 Safety of laser products. Part 1: Equipment classification and requirements: IEC 62366: 2007/ A 1 :2014; EN 62366: 2008 Medical devices-Application of usability engineering to medical devices, and with IEC 60601-1-6: 2010: EN 60601-1-6: 2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance-Collateral standard: Usability.
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Summary of Substantial Equivalence:
The submission and predicate device have substantially equivalent technical and performance characteristics including: power level; energy delivered; aiming beam; laser medium; cooling methods; anatomical sites applicable; warnings and contraindications; and for use on the general population. The raw materials and electrical components of the submission and predicate device have a substantially equivalent design and operating controls.
Where there are differences between the submission and the predicate device K150140, a review of the data showed that the differences did not represent new unacceptable risk to the patient of the device. After review of the subject and predicate devices, including technical, performance, and design information as mentioned above, it is concluded that the device in this 510(k) and the predicate device are substantially equivalent.