(277 days)
Not Found
No
The summary describes a laser-based skin treatment system with different modules for various dermatological procedures. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or performance studies. The focus is on the physical delivery of laser light and standard electrical and laser safety testing.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for the "treatment of psoriasis and vitiligo" and for "dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures," "treatment of dyschromia and cutaneous lesions," and "treatment of periorbital wrinkles, acne scars and surgical scars." These are all therapeutic applications. Furthermore, the submitted testing reports include IEC 60601-2-22 Edition 3.1 2012-10: Medical Electrical Equipment Part 2-22: -Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment, directly mentioning "Therapeutic" as a classification for the laser equipment.
No
The device description clearly states its intended uses are for treatment (e.g., psoriasis, vitiligo, coagulation of soft tissue, skin resurfacing, treatment of dyschromia, lesions, wrinkles, scars). There is no mention of it being used for diagnosis, only therapy.
No
The device description clearly outlines hardware components such as a base unit, laser modules, handpieces, scanners, applicators, electrical cables, a touch-screen, and an optical fiber. This indicates it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a "multi-modality skin surface treatment system" used for treating conditions like psoriasis, vitiligo, dyschromia, lesions, wrinkles, and scars. These are all therapeutic applications performed directly on the patient's skin.
- Device Description: The description details a system that delivers light (UVB and Infrared laser) to the skin surface. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
In summary, the FlexSys system is a therapeutic device that applies energy to the skin for treatment purposes, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.
Modules UVB EPL 308 and UVB EPL 308 lite:
The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Module Infrared 1550:
The GME FlexSys System with Infrared 1550 module is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
Product codes (comma separated list FDA assigned to the subject device)
GEX, FTC
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 there. 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.
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)
Testing reports were submitted for the following standards:
- IEC 60825-1 Edition 2.0 2007-03: Safety of Laser Products Part 1: Equipment -Classification, and Requirements
- IEC 60601-2-22 Edition 3.1 2012-10: Medical Electrical Equipment Part 2-22: -Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
- -IEC 60601-1:2005, AMD1:2012: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- -IEC 60601-1-2:2014: Medical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
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.
K130193 Solta Medical Inc., Fraxel DUAL 1550/1927 Laser System, K150752 GME ExSys 308, K171702, K191086 Clarteis Exciplex308nm
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
Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 10, 2023
GME German Medical Engineering GmbH Dietmar Fischer Technical Director Dreikoenigstr. 6-8 Erlangen, Bavaria 91054 Germany
Re: K221623
Trade/Device Name: FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm 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, FTC Dated: December 6, 2022 Received: December 12, 2022
Dear Dietmar Fischer:
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 (QS) 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.
Jianting Wang -S
Jianting Wang Acting 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) K221623
Device Name FlexSys
Indications for Use (Describe)
The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.
Modules UVB EPL 308 and UVB EPL 308 lite:
The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Module Infrared 1550:
The GME FlexSys System with Infrared 1550 module is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
| 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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3
510(k) Summary K221623
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92. Summary preparation date 2023-03-08 [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 Contact person: Dr. Dietmar Fischer Dietmar.fischer@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, FTC Device Classification: Class II
D. Predicate Devices [21 CFR 807.92(a)(3)]
The FleySys uses similar technology and physical output characteristics as the following predicate devices: K130193 Solta Medical Inc., Fraxel DUAL 1550/1927 Laser System K150752 GME ExSys 308 K171702, K191086 Clarteis Exciplex308nm
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 there. The touch-screen serves as the main control panel.
4
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.
F. Indications for Use [21 CFR 807.92(a)(5)]
The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.
Modules EPL 308 and EPL 308 lite:
The GME Flex.Sys System with module EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Module Infrared 1550:
The GME Flex.Sys System with Infrared 1550 module is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
G. 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 six different modules. Thus, the predicate devices will vary from module to module. Three of these modules have already been approved, see K203054. Thus this comparison to predicates only deals with the remaining three modules, the Infrared 1550mm module and the two UVB 308nm modules.
5
The predicate devices used to argue substantial equivalence are the GME ExSys 308 (K150752) and Clarteis Exciplex (K171702, K191086) for the UVB 308nm modules, and the Solta Fraxel DUAL (K130193) for the Infrared 1550nm module.
The equivalence comparisons for the UVB 308 nm wavelengths use the predicates GME ExSys 308 and Clarteis Exciplex.
The equivalence comparisons for the infrared 1550 nm laser wavelength use the predicate Solta Fraxel DUAL.
| Characteristic | GME FlexSys
System
Module EPL 308
"FlexSys EPL 308" | GME FlexSys
System
Module EPL 308 lite
"FlexSys EPL 308 lite" | GME ExSys 308
"ExSys 308" | Clarteis
Exciplex308nm
"Exciplex" |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Applicable 510(k)s | NA | NA | K150752 | K171702, K191086 |
| Panel/ | General and Plastic
Surgery | General and Plastic
Surgery | General and Plastic
Surgery | General and Plastic
Surgery |
| Product Code/ | FTC | FTC | FTC | FTC |
| Regulation
Number | 21 CFR 878.4630 | 21 CFR 878.4630 | 21 CFR 878.4630 | 21 CFR 878.4630 |
| Indications for Use
Statement | The GME FlexSys
System with module
EPL 308 is intended
to be used for the
treatment of
psoriasis and
vitiligo. It is to be
used on intact skin
only | The GME FlexSys
System with module
EPL 308 lite is
intended to be used
for the treatment of
psoriasis and
vitiligo. It is to be
used on intact skin
only | The GME ExSys
308 System is
intended to be used
for the treatment of
psoriasis and
vitiligo. It is to be
used on intact skin
only. | The Exciplex308nm
is intended to be
used for the
treatment of
psoriasis, vitiligo,
atopic dermatitis,
and leukoderma. |
| Classification | Class II | Class II | Class II | Class II |
| Common Name | Ultraviolet lamp for
dermatologic
disorders | Ultraviolet lamp for
dermatologic
disorders | Ultraviolet lamp for
dermatologic
disorders | Ultraviolet lamp for
dermatologic
disorders |
| Mechanism of
Action | UVB light
penetrates the skin
and modulates the
immune system and
stimulates
melanocytes to
produce melanin | UVB light
penetrates the skin
and modulates the
immune system and
stimulates
melanocytes to
produce melanin | UVB light
penetrates the skin
and modulates the
immune system and
stimulates
melanocytes to
produce melanin | UVB light
penetrates the skin
and modulates the
immune system and
stimulates
melanocytes to
produce melanin |
1. UVB modules
2. Infrared 1550 module
| Characteristic | GME FlexSys System | Solta Fraxel DUAL
1550/1927 Laser System |
|----------------|----------------------------|---------------------------------------------|
| - | Module Infrared 1550 | |
| - | "FlexSys Infrared
1550" | "Fraxel" |
6
| Applicable
| 510(k)s | NA | K130193 |
|---|---|---|
| Panel/ | General and Plastic | |
| Surgery | General and Plastic Surgery | |
| Product Code/ | GEX | GEX |
| Regulation | ||
| Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications for | ||
| Use Statement | The GME FlexSys | |
| System with Infrared | ||
| 1550 module is indicated | ||
| for use in dermatological | ||
| procedures requiring the | ||
| coagulation of soft tissue, | ||
| as well as for skin | ||
| resurfacing procedures. It | ||
| is also indicated for | ||
| treatment of dyschromia | ||
| and cutaneous lesions, | ||
| such as, but not limited to | ||
| lentigos (age spots), solar | ||
| lentigos (sun spots), | ||
| actinic keratosis, and | ||
| melasma, and for | ||
| treatment of periorbital | ||
| wrinkles, acne scars and | ||
| surgical scars. | The Fraxel 1550 nm laser is | |
| indicated for use in | ||
| dermatological procedures | ||
| requiring the coagulation of | ||
| soft tissue, as well as for skin | ||
| resurfacing procedures. It is | ||
| also indicated for treatment of | ||
| dyschromia and cutaneous | ||
| lesions, such as, but not | ||
| limited to lentigos (age spots), | ||
| solar lentigos (sun spots), | ||
| actinic keratosis, and | ||
| melasma, and for treatment of | ||
| periorbital wrinkles, acne | ||
| scars and surgical scars. | ||
| Classification | Class II | Class II |
| Common Name | Laser surgical instrument | |
| for use in general and | ||
| plastic surgery and in | ||
| dermatology | Laser surgical instrument for | |
| use in general and plastic | ||
| surgery and in dermatology | ||
| Mechanism of | ||
| Action | Heats water in skin | |
| through the absorption of | ||
| light. The heating | ||
| denatures the skin and | ||
| stimulates a healing | ||
| reaction by the skin. | Heats water in skin through | |
| the absorption of light. The | ||
| heating denatures the skin and | ||
| stimulates a healing reaction | ||
| by the skin. |
H. Performance Data [21 CFR 807.92(b)(2)]
The Guidance Document, Laser Products – Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice 56) January 19, 2018 was used.
Testing reports were submitted for the following standards:
- IEC 60825-1 Edition 2.0 2007-03: Safety of Laser Products Part 1: Equipment -Classification, and Requirements
- IEC 60601-2-22 Edition 3.1 2012-10: Medical Electrical Equipment Part 2-22: -Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
- -IEC 60601-1:2005, AMD1:2012: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
7
- -IEC 60601-1-2:2014: Medical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
- I. Conclusion [21 CFR 807.92(b)(3)]
The GME FlexSys System is substantially equivalent to the predicate devices; in terms of technology, function and indications for use. There are no new questions of safety or efficacy raised by the introduction of the FlexSys System.