(149 days)
No
The summary describes a light-based skin treatment device with different modules and wavelengths. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or performance studies.
Yes
The device is described as treating various dermatological and medical conditions, such as inflammatory acne vulgaris, periorbital wrinkles, vascular lesions, and pigmented lesions, which falls under the definition of a therapeutic device designed to alleviate or heal medical conditions.
No
Explanation: The "Intended Use / Indications for Use" section describes various treatment applications for dermatological conditions, periorbital wrinkles, and benign lesions. There is no mention of the device being used for diagnosis or identifying medical conditions.
No
The device description clearly outlines a physical base unit, handpieces, scanners, applicators, cables, and optical fibers, indicating it is a hardware-based medical device that utilizes light for treatment.
Based on the provided information, the device FlexSys 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.
- FlexSys Function: The description of the FlexSys device clearly indicates it is a "multi-modality skin surface treatment" device that uses light (various wavelengths) to treat dermatological conditions, wrinkles, and lesions. It applies light directly to the skin.
- No Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its operation involves direct interaction with the skin surface.
Therefore, the FlexSys device falls under the category of a therapeutic device that applies energy to the body, rather than an in vitro diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The device FlexSys is a multi-modality skin surface treatment . Depending on the chosen modules the intended use and the mode of operation varies.
Module MultiLite:
The intended use of the device FlexSys with MultiLite module is:
· Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
· Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
· Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions.
Module Green 532:
The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Module Yellow 577:
The GME FlexSys with module Yellow 577 (wavelength: 577mm) is intended for treatment of benign vascular and benign pigmented lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.
The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition the power cord, foot switch, and the door plug are connected to the base unit. The touch-screen serves as the main control panel.
The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.
The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.
During development and manufacturing applicable directives, legal requirements and standards for medical devices were considered. Our product complies to them.
If you turn on the device, then the unit performs several tests automatically. Thereby the proper functioning of the device - according to the specifications - is ensured. As soon as these tests have been completed successfully, the device is ready for parameter selection and patient treatment. In addition to the initial tests a number of device functions and parameters are monitored continuously.
If the unit detects abnormalities or defects, then it reacts depending on the nature and importance by a notice, a warning or error message. This message needs to be confirmed by the user. Depending on the message one of the following cases is possible:
- the user needs to perform an action to eliminate the cause of the message (Example: ● The user has to take his foot off the foot switch or order a device service)
- the user must wait for a change of parameters (Example: the temperature of the device is too low, the user must wait until the unit has warmed up sufficiently.)
- . the device attempts to resolve the cause of the error and performs a re-test (Example: a too high / low laser power was measured. The device performs an adjustment of power. )
- A reboot of the device is required. The device asks the user to initiate a restart. .
Essential performance of the device:
- -The radiation wavelength of the single modules has to lie in the range specified in the tables of section 7.1 of this user manual. This device property is tested by the manufacturer during production. No repeat measurement of this necessary.
- -The light power of all laser modules has to stay within +-20% of its nominal value. This device property is check by the manufacturer during production. The light power is continuously monitored during laser emission. Laser emission will be stopped and error messages will be shown if values outside the +-20% range are detected. The calibration of the laser modules is checked by the service technician during the maintenance specified in section 6.3. The device will notify the user about necessary maintenance works. Appropriate laser power meters are used to calibrate the device in service mode according to the service instructions provided by GME.
- -The applied light dose (=fluence) of all modules has to stay within +-20% of its nominal value. This device property is checked by the manufacturer during production. The applied dose is calculated from the actual light power and the emission time during light emission. In case of too high or too low dose values light emission will be stopped and the user will be notified. The calibration of the modules is checked by the service technician during the maintenance specified in section 6.3. The device will notify the user about necessary maintenance works. Appropriate laser or light power meters are used to calibrate the device in service mode according to the service instructions provided by GME.
Principle of Operation:
- For the Green 532 and Yellow 577 modules: Visible light penetrates tissue up to a ● depth of about 1 mm. When the laser radiation hits the skin, the light is mainly absorbed by melanin and hemoglobin in the skin. Melanin and hemoglobin-containing structures such as pigment spots or blood vessels heat up more strongly than the surrounding skin. This causes irreversible damage or coagulation of the structures.
- . For the MultiLite module: Visible light penetrates tissue up to a depth of about 10 mm. Light at this wavelength is beneficial in treating bengin dermatological lesions. LED photo modulation with visible light reverses signs of aging using a nonthermal mechanism.
Blue, LED therapy can destroy the bacteria associated with acne lesions because the light generates oxygen radicals in very active cells (like bacteria or cancer cells) which destroy the cell walls and thus lead to necrosis or apostosis of the cells.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Clinical Performance Data: None
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.
K031425 LightBio Science L.L.C., Gentle Waves, K120460 Medmix Co. Ltd., SMARTLUX, K133297 Asclepion Laser Technologies GmbH, QuadroStar PRO
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 5, 2021
GME German Medical Engineering GmbH Katja Kerl Regulatory Affairs Dreikoenigstrasse 6-8 Erlangen, Bavaria 91054 Germany
Re: K203054
Trade/Device Name: FlexSys 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: August 18, 2020 Received: October 7, 2020
Dear Katja Kerl:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203054
Device Name FlexSys
Indications for Use (Describe)
The device FlexSys is a multi-modality skin surface treatment . Depending on the chosen modules the intended use and the mode of operation varies.
Module MultiLite:
The intended use of the device FlexSys with MultiLite module is:
· Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
· Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
· Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions.
Module Green 532:
The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Module Yellow 577:
The GME FlexSys with module Yellow 577 (wavelength: 577mm) is intended for treatment of benign vascular and benign pigmented lesions.
Type of Use (Select one or both, as applicable)
| X Registration for OFF-HIGHWAY Vehicle | Use for Competition OFF-HIGHWAY Vehicle |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary K203054
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 01-19-2021 [21 CFR 807.92(a)(1)].
A. Applicant Name and Address [21 CFR 807.92(a)(1)]
GME German Medical Engineering GmbH. Dreikoenigstrasse 6-8 91054 Erlangen Bavaria, Germany Tel: +49 9131 934159 10 Fax: +49 9131 934159 99
B. Contact Information
GME German Medical Engineering GmbH. Dreikoenigstrasse 6-8 91054 Erlangen Bavaria, Germany Tel: +49 9131 934159 00 Fax: +49 9131 934159 99 Contact person: 1.)
Dr. Dietmar Fischer (technical director), Phone: +49 9131 93415911 e-mail: dietmar.fischer@gmeonline.de
- 2.) Katja Kerl (regulatory affairs) Phone: +49 9131 93415918 e-mail: katja.kerl@gmeonline.de
C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name: FlexSys
Device Common Name: Laser Instrument for Dermatology Classification Name: Laser Instrument, Surgical Powered 21 CFR 878.4810 Product Code: GEX Device Classification: Class II
D. Predicate Devices [21 CFR 807.92(a)(3)]
The FlexSys uses similar technology and physical output characteristics as the following predicate devices: K031425 LightBio Science L.L.C., Gentle Waves, and K120460 Medmix Co. Ltd., SMARTLUX K133297 Asclepion Laser Technologies GmbH, QuadroStar PRO
4
E. Device Description [21 CFR 807.92(a)(4)]
The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.
The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition the power cord, foot switch, and the door plug are connected to the base unit. The touch-screen serves as the main control panel.
The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.
The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.
During development and manufacturing applicable directives, legal requirements and standards for medical devices were considered. Our product complies to them.
If you turn on the device, then the unit performs several tests automatically. Thereby the proper functioning of the device - according to the specifications - is ensured. As soon as these tests have been completed successfully, the device is ready for parameter selection and patient treatment. In addition to the initial tests a number of device functions and parameters are monitored continuously.
If the unit detects abnormalities or defects, then it reacts depending on the nature and importance by a notice, a warning or error message. This message needs to be confirmed by the user. Depending on the message one of the following cases is possible:
- the user needs to perform an action to eliminate the cause of the message (Example: ● The user has to take his foot off the foot switch or order a device service)
- the user must wait for a change of parameters (Example: the temperature of the device is too low, the user must wait until the unit has warmed up sufficiently.)
- . the device attempts to resolve the cause of the error and performs a re-test (Example: a too high / low laser power was measured. The device performs an adjustment of power. )
- A reboot of the device is required. The device asks the user to initiate a restart. .
Essential performance of the device:
5
- -The radiation wavelength of the single modules has to lie in the range specified in the tables of section 7.1 of this user manual. This device property is tested by the manufacturer during production. No repeat measurement of this necessary.
- -The light power of all laser modules has to stay within +-20% of its nominal value. This device property is check by the manufacturer during production. The light power is continuously monitored during laser emission. Laser emission will be stopped and error messages will be shown if values outside the +-20% range are detected. The calibration of the laser modules is checked by the service technician during the maintenance specified in section 6.3. The device will notify the user about necessary maintenance works. Appropriate laser power meters are used to calibrate the device in service mode according to the service instructions provided by GME.
- -The applied light dose (=fluence) of all modules has to stay within +-20% of its nominal value. This device property is checked by the manufacturer during production. The applied dose is calculated from the actual light power and the emission time during light emission. In case of too high or too low dose values light emission will be stopped and the user will be notified. The calibration of the modules is checked by the service technician during the maintenance specified in section 6.3. The device will notify the user about necessary maintenance works. Appropriate laser or light power meters are used to calibrate the device in service mode according to the service instructions provided by GME.
Principle of Operation:
- For the Green 532 and Yellow 577 modules: Visible light penetrates tissue up to a ● depth of about 1 mm. When the laser radiation hits the skin, the light is mainly absorbed by melanin and hemoglobin in the skin. Melanin and hemoglobin-containing structures such as pigment spots or blood vessels heat up more strongly than the surrounding skin. This causes irreversible damage or coagulation of the structures.
- . For the MultiLite module: Visible light penetrates tissue up to a depth of about 10 mm. Light at this wavelength is beneficial in treating bengin dermatological lesions. LED photo modulation with visible light reverses signs of aging using a nonthermal mechanism.
Blue, LED therapy can destroy the bacteria associated with acne lesions because the light generates oxygen radicals in very active cells (like bacteria or cancer cells) which destroy the cell walls and thus lead to necrosis or apostosis of the cells.
F. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)]
The FlexSys Platform is a multi-modality skin treatment device that can be equipped with up to three different modules. Thus the predicate devices will vary from module to module.
The predicate devices used to demonstrate substantial equivalence are the the Asclepion QuadroStar Pro (K133297), the Medmix Smartlux (K120460), and the Light Bioscience GentleWaves (K031425).
The equivalence comparisons for the visible 532 nm and 577 nm laser wavelengths use the predicate Asclepion QuadroStar Pro (K133297).
The equivalence comparisons for the visible LED module Multilite use the predicates Medmix Smartlux (K120460) and Light Bioscience GentleWaves (K003142).
6
| Characteristic | GME FlexSys | GME FlexSys | Asclepion QuadroStarPRO |
|---|---|---|---|
| Module Green 532 | |||
| "FlexSys Green 532" | Module Yellow 577 | ||
| “FlexSys Yellow 577" | "QuadroStar" | ||
| Applicable | |||
| 510(k)s | NA | NA | K133297 |
| Panel/ | General and Plastic | ||
| Surgery | General and Plastic Surgery | General and Plastic Surgery | |
| Product Code/ | GEX | GEX | GEX |
| Regulation | |||
| Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications for | |||
| Use Statement | NA | The GME FlexSys with | |
| module Yellow 577 | |||
| (wavelength: 577nm) is | |||
| intended for treatment of | |||
| benign vascular and benign | |||
| pigmented lesions. | The QuadroStarPRO | ||
| YELLOW (wavelength: | |||
| 577nm) is | |||
| intended for treatment of | |||
| benign vascular and benign | |||
| pigmented lesions. | |||
| The GME FlexSys with | |||
| module Green 532 | |||
| (wavelength: 532nm) is | |||
| intended for vaporization | |||
| and photocoagulation of | |||
| benign vascular and | |||
| benign pigmented lesions | |||
| in soft tissue. | NA | The QuadroStarPRO GREEN | |
| (wavelength: 532nm) is | |||
| intended for vaporisation and | |||
| photocoagulation of benign | |||
| vascular and benign | |||
| pigmented lesions in soft | |||
| tissue. | |||
| Classification | Class II | Class II | Class II |
| Common Name | Diode-pumped solid state | ||
| laser | Diode-pumped solid state laser | Diode-pumped solid state laser | |
| Mechanism of | |||
| Action | Heats chromophores | ||
| (vessels or pigments) and | |||
| water in the skin through | |||
| the absorption of light. | |||
| The heating denatures the | |||
| target structures. | Heats chromophores (vessels | ||
| or pigments) and water in the | |||
| skin through the absorption of | |||
| light. The heating denatures | |||
| the target structures. | Heats chromophores (vessels | ||
| or pigments) and water in the | |||
| skin through the absorption of | |||
| light. The heating denatures | |||
| the target structures. |
1. Green 532 and Yellow 577 module
2. MultiLite module
| Characteristic | GME FlexSys | Medmix Smartlux | Light Bioscience
GentleWaves LED
Photomodulation Device |
|-----------------------|----------------------------------------|-----------------------------|---------------------------------------------------------------|
| | Module MultiLite
"FlexSys MutiLite" | "Smartlux" | "GentleWaves" |
| Applicable
510(k)s | NA | K120460 | K031425 |
| Panel/ | General and Plastic Surgery | General and Plastic Surgery | General and Plastic Surgery |
7
| Product Code/ | GEX | GEX | GEX |
|---|---|---|---|
| Regulation | |||
| Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications for | |||
| Use Statement | Blue: Dermatological | ||
| conditions and specifically | |||
| treatment of moderate | |||
| inflammatory acne vulgaris | 415nm wavelength: | ||
| Dermatological conditions | |||
| and specifically indicated to | |||
| treat moderate inflammatory | |||
| acne vulgaris | NA | ||
| Yellow: Treatment of | |||
| periorbital wrinkles and | |||
| rhytides | 588nm wavelength: The | ||
| GentleWaves LED | |||
| Photomodulation Device is | |||
| indicated/intended for use in | |||
| the treatment of periorbital | |||
| wrinkles and rhytides | |||
| Red: Treatment of superficial, | |||
| benign vascular, and | |||
| pigmented lesions | 633nm wavelength: | ||
| Dermatology for treatment of | |||
| superficial, benign vascular, | |||
| and pigmented lesions | NA | ||
| Classification | Class II | Class II | Class II |
| Common Name | LED light source | LED light source | LED light source |
| Mechanism of | |||
| Action | Reduces inflammation and | ||
| stimulates collagen | |||
| production via | |||
| photomodulation effect of the | |||
| light penetrating the skin. | Reduces inflammation and | ||
| stimulates collagen | |||
| production via | |||
| photomodulation effect of the | |||
| light penetrating the skin. | Stimulates collagen | ||
| production via | |||
| photomodulation effect of the | |||
| light penetrating the skin. |
G. Indications for Use [21 CFR 807.92(a)(5)]
The device FlexSys is a multi-modality skin surface treatment . Depending on the chosen modules the intended use and the mode of operation varies.
Module MultiLite:
The intended use of the device FlexSys with MultiLite module is:
- . Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
- Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally ● indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
- Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general ● to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions.
8
Module Green 532:
The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Module Yellow 577:
The GME FlexSys with module Yellow 577 (wavelength: 577mm) is intended for treatment of benign vascular and benign pigmented lesions.
H. Discussion of nonclinical tests [21 CFR 807.92(b)(1)]
The Guidance Document, Laser Products – Conformance with EN 60825-1:2015-07 and EN 60601-2-22: 2015-08 (Laser Notice 56: 2018-05-08) was used. Testing reports for EN 60825-1:2015-07 and EN 60601-2-22:2015-08 were submitted. Testing reports for EN 60601-1:2013-12 and EN 60601-1-2:2016-05 were also submitted. The European version of the standards (EN) have been used for the tests. but they are identical in all test requirements to the IEC versions of the standards.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Sofware documentation provided is consistent with a moderate level of concern.
Biocompatibility:The body-contacting component for the FlexSys uses identical stainless-steel material as in FDA cleared reference devices Wavelight IDAS (K053604) and Wavelight ARION (K042474). Therefore, biocompatibility testing is not required.
Usability was established based on standards EN 62366-1:2015 + AC:2015 and EN 60601-1-6:2010+A1:2015
Shelf life was established to be 10 years.
Clinical Performance Data: None
I. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of technology, function, indications for use, design, materials and performance, The GME FlexSys is to be concluded substantially equivalent to the predicate devices. There are no new questions of safety or efficacy raised by the introduction of the FlexSys.