(90 days)
Not Found
No
The provided text describes a standard diode laser system for hair removal. There is no mention of AI, ML, image processing, or any other technology that would typically indicate the presence of AI/ML capabilities. The description focuses on the hardware components and the physical principle of operation.
Yes
The device is indicated for "hair removal and permanent hair reduction," which involves a physical change to the hair follicle through heating to retard hair growth, thus serving a therapeutic purpose.
No.
The device is indicated for hair removal and permanent hair reduction and is described as a diode laser system for stable, long-term hair reduction, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components including a base unit, applicator unit with a diode laser and scanner, power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. 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 is for hair removal and permanent hair reduction. This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Principle of Operation: The device uses laser light to heat and denature proteins in hair follicles. This is a physical interaction with the patient's tissue.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
The GME TwinScan 808/755 Laser System is a medical device used for a dermatological treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The GME TwinScan 808/755 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-VI).
Product codes
GEX
Device Description
The TwinScan 808/755 Laser System is a diode laser designed to be used in Dermatological practice for stable, long term hair reduction.
The TwinScan 808/755 Laser System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner. The device may be configured with 808 nm or 755 nm Applicators, in two treatment area sizes, at the factory. The TwinScan 808/755 Laser System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the TwinScan 808/755 Laser System.
Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore (in this case, hair follicle). Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 for IEC 60825-1 and IEC 60601-2-22 were submitted. Testing reports for IEC 60601-1 and IEC 60601-1-2 were also submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 19, 2019
GME German Medical Engineering GmbH % Mike Johnson Consultant Philosopher's River LLC P O Box 106 Willow Creek, Montana 59760
Re: K192269
Trade/Device Name: TwinScan 808/755 Laser System 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 6, 2019 Received: August 21, 2019
Dear Mike Johnson:
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
1
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 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,
Purva Pandva 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) K192269
Device Name TwinScan 808/755 Laser System
Indications for Use (Describe)
The GME TwinScan 808/755 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-V).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K192269
510(k) Summarv
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 08-08-2019 [21 CFR 807.92(a)(1)].
A. Applicant Name and Address [21 CFR 807.92(a)(1)]
GME German Medical Engineering GmbH.
Grimmstrasse 23
Germany 90491
Tel: +49 9131 934159 10
Fax: +49 9131 934159 99
B. Contact Information
Philosopher's River Ilc
P O Box 106
Willow Creek, MT 59760
Tel: 406-209-3039
Fax: 406 209 3039
Contact person: Mike Johnson M.D.
C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name: TwinScan 808/755 Laser System Device Common Name: Laser Instrument for Dermatology Classification Name: Laser Instrument, Surgical Powered 21 CFR 878.4810 Product Code: GEX Device Classification: Class II
4
D. Predicate Devices [21 CFR 807.92(a)(3)]
The TwinScan 808/755 Laser System uses similar technology and physical output characteristics as the following predicate devices: K180518 GME LinScan Lite 808 System, and K143519 Asclepion MeDioStar NEXT
E. Device Description [21 CFR 807.92(a)(4)]
The TwinScan 808/755 Laser System is a diode laser designed to be used in Dermatological practice for stable, long term hair reduction.
The TwinScan 808/755 Laser System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner. The device may be configured with 808 nm or 755 nm Applicators, in two treatment area sizes, at the factory. The TwinScan 808/755 Laser System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the TwinScan 808/755 Laser System.
Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore (in this case, hair follicle). Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.
F. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)]
The GME TwinScan 808/755 Laser System is compared to the predicates
The indications for use and classification for the TwinScan 808/755 Laser System are equivalent to the predicates. Below is a comparison table of specifications.
| Characteristic | GME TwinScan 808/755
Laser System | GME LinScan Lite 808
Laser System | Asclepion MeDioStar
NeXT PRO XL |
|-----------------------|--------------------------------------|--------------------------------------|------------------------------------|
| | "TwinScan" | "LinScan 808" | "MeDioStar" |
| Applicable
510(k)s | NA | K180518 | K143519 |
5
| Panel/ | General and Plastic
Surgery | General and Plastic Surgery | General and Plastic
Surgery |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code/
Regulation
Number | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 |
| Indications for
Use Statement | The GME TwinScan
808/755 Laser System is
indicated for hair removal
and permanent hair
reduction defined as the
stable, long-term reduction
in hair counts at 6, 9, or 12
months following a
treatment regime.
The GME TwinScan
808/755 Laser System is
intended to be used on all
skin types
(Fitzpatrick I-VI). | The GME LinScan Lite 808
Laser System is indicated
for hair removal and
permanent hair reduction
defined as the stable, long-
term reduction in hair counts
at 6, 9, or 12 months
following a treatment
regime.
The GME LinScan Lite 808
System is intended to be
used on all skin types
(Fitzpatrick I-VI). | The MeDioStar NeXT
Family laser system is
intended for hair removal
and permanent hair
reduction defined as
reduced hair growth with
or without maintenance
when measured at 6, 9 and
12 months.
The MeDioStar NeXT
Family laser system is
intended for the treatment
of benign vascular lesions.
The MeDioStar NeXT
Family laser system is
intended for the treatment
of benign pigmented
lesions. |
| Classification | Class IV | Class IV | Class IV |
| Common Name | Pulsed diode laser | Pulsed diode laser | Pulsed diode laser |
| Mechanism of
Action | Heats chromophores
(pigments) and water in the
skin through the absorption
of light. The heating
denatures proteins of the
hair follicle | Heats chromophores
(pigments) and water in the
skin through the absorption
of light. The heating
denatures proteins of the
hair follicle. | Heats chromophores
(pigments) and water in
the skin through the
absorption of light. The
heating denatures proteins
of the hair follicle. |
| Characteristic | GME TwinScan 808/755
Laser System
"TwinScan" | GME LinScan Lite
808
"LinScan Lite 808" | Asclepion MeDioStar
NeXT PRO XL
"MeDioStar" |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------|
| Applicable
510(k)s | NA | K180518 | K143519 |
| Mode of
Operation | Pulsed diode laser | Pulsed diode laser | Pulsed diode laser |
| Light Source | Laser diode | Laser diode | Laser diode |
| Light Delivery | Laser and scanner are in the
Applicator handpiece | Laser and scanner are in
the Applicator handpiece | Laser is in handpiece |
| Cooling of Skin | Sapphire provides contact
cooling | Sapphire provides
contact cooling. | Sapphire provides contact
cooling. |
| Treatment Area
Size | f-hp - applicator:
15 x 13 mm,
15 x 50 mm or 15 x 25 mm
p-hp - applicator:
10 x 25 mm, 10 x 13 mm | 10 x 25 mm, 10 x 13
mm | 14 x 10 mm.
4 x 3 mm,
8 x 6 mm,
30 x 10 mm,
38 x 24 mm |
| Peak Power | Up to 300 W | Up to 150W | 2400W |
| Power Density | See wavelength comparison | See wavelength
comparison | See wavelength comparison |
| Fluence
(Energy Density
per Flash) | See wavelength comparison | See wavelength
comparison | See wavelength comparison |
| Pulse Duration | 4-100ms | 4-100ms | Up to 400ms |
| Repetition Rate | up to 10 Hz | up to 2 Hz | 4 to 12 Hz |
| System Cooling | Self contained, closed water
circulation system | Self contained, closed
water circulation system | Self contained, closed
water circulation system |
| Wavelength | 755 nm or 808 nm | 808 nm | 755 nm, 808 nm
or 940 nm |
| Beam Mode | Multimode | Multimode | Multimode |
| Aiming Beam | None | None | None |
| Controls | Footswitch or handswitch | Footswitch or
handswitch | Footswitch or handswitch |
| Electrical
Requirements | 100 V-240 V @ 50/60 Hz,
max.1750 W | 100V-240V @ 50/60Hz,
max. 900W | 100 -240 VAC, 50/60 Hz,
max. 1500W |
| Power
Calibration
Method | Diode current calibrated by
external power ruler | Diode current calibrated
by external power ruler | Diode current calibrated by
external power ruler |
| Sterilization
Aspects | Applicator is cleaned /
disinfected between patients. | Applicator is cleaned /
disinfected between patients. | Applicator is cleaned /
disinfected between patients. |
| Pulse Formation | CW current switched on / off | CW current switched on / off | CW current switched on / off |
| Pulse Train
Duration | 4 ms – 100 ms | 4 ms – 100 ms | Up to 400 ms |
| Beam Diameter | f-hp applicator:
1mm x 15mm
p-hp applicator:
0.75 mm x 10 mm | 0.75 mm x 10 mm | 14 x 10 mm,
4 x 3 mm,
8 x 6 mm,
30 x 10 mm,
38 x 24 mm |
| Duty Cycle |