(82 days)
Not Found
No
The description focuses on the laser technology and its mechanism of action, with no mention of AI or ML.
No
Explanation: The device is indicated for hair removal and permanent hair reduction, which are considered cosmetic procedures rather than treatments for a disease, injury, or other medical condition.
No
The device is indicated for hair removal and permanent hair reduction, which are treatment procedures, not diagnostic ones. It works by heating hair follicles to retard growth, not by diagnosing conditions.
No
The device description clearly states it is a diode laser system consisting of a base unit and applicator unit containing the laser and scanner, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The GME LinScan System is a laser system designed for hair removal and permanent hair reduction by targeting pigment in hair follicles. It directly interacts with the patient's skin and hair.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. Its operation is based on the interaction of laser light with the patient's tissue.
Therefore, based on the provided information, the GME LinScan System is a therapeutic device used for a cosmetic/medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GME LinScan System with the applicators LinScan 808 and LinScan 980 is indicated for hair removal and permanent hair reduction defined as the stable, longterm reduction in hair counts at 6, 9,or 12 months following a treatment regime.
Product codes
GEX
Device Description
The LinScan is a diode laser system designed to be used in Dermatological practice for stable, long term hair reduction.
The LinScan System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button), which controls an applicator unit. The applicator unit contains the diode laser and scanner. The unit comes in two models: the LinScan 808 has an applicator with a 808 nm diode laser. The LinScan 980 has an applicator with a 980 nm diode laser.
The LinScan 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 LinScan System.
Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). 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
Dermatological practice
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 50) June 24, 2002 was used. Third party testing reports for IEC 60825-1 and IEC 60601-2-22 were 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
K141063
Section 5
JUL 15 2014
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 03-08-2014 [21 CFR 807.92(a)(1)].
Applicant Name and Address [21 CFR 807.92(a)(1)] A.
GME German Medical Engineering GmbH.
Grimmstrasse 23
Bavaria, Germany 90491
Tel: +49 9131 934159 10
Fax: +49 9131 934159 99
B. Contact Information
Philosopher's River IIc
P O Box 106
Willow Creek, MT 59760
Tel: 406-209-3039
Fax: 406 2093039
Contact person: Mike Johnson M.D.
1
K141063
Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] C.
Trade Name: LinScan 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
D. Predicate Devices [21 CFR 807.92(a)(3)]
The LinScan System uses similar technology and physical output characteristics as the following predicate devices: K090762 LEDA from Quantel Derma GmbH
Device Description [21 CFR 807.92(a)(4)] E.
The LinScan is a diode laser system designed to be used in Dermatological practice for stable, long term hair reduction.
The LinScan System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button), which controls an applicator unit. The applicator unit contains the diode laser and scanner. The unit comes in two models: the LinScan 808 has an applicator with a 808 nm diode laser. The LinScan 980 has an applicator with a 980 nm diode laser.
The LinScan 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 LinScan System.
Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.
5-2
2
F. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)]
The LinScan is compared to the predicate, the Quantel Derma LEDA. The indications for use and intended use for the LinScan are identical to the Quantel Derma LEDA. Below is a comparison table.
| Characteristic | GME Linscan with
applicators LinScan 808 and
LinScan 980 | Quantel Derma LEDA System
with applicators LEDA EPI
808 and LEDA EPI 980 |
|------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Applicable 510(k)s | NA | K090762 |
| Mode of Operation | Pulsed diode laser | Pulsed diode laser |
| Light Source | Laser diode | Laser diode |
| Light Delivery | Laser and scanner
are in the
Applicator
handpiece | Laser and scanner are in the Applicator
handpiece |
| Cooling of Skin | Sapphire provides
contact cooling. | Sapphire provides contact cooling or
optional air cooling. |
| Treatment Area
Size | 15 x 10 mm or 15
x 50 mm | 12 x 12 mm or 12 x 50 mm |
| Peak Power | Up to 300W | Up to 350 W |
| Fluence
(Energy Density
per Flash) | 4-100 J/cm² | 15-60 J/cm² (LEDA EPI 808)
15-90 J/cm² (LEDA EPI 980) |
| Pulse Widths | 4-100 ms | 6-60 ms |
| Repetition Rate | 0.5 to 2 pulses per
second depending
on energy | 0.5 to 1 pulse per second depending on
energy. |
| System Cooling | Self contained,
closed water
circulation system | Self contained, closed water circulation
system |
| Wavelength | 808 nm (LinScan
808)
980 nm (LinScan
980) | 808 nm (LEDA EPI 808)
980 nm (LEDA EPI 980) |
| Beam Mode | Multimode | Multimode |
| Beam Divergence
Angel | 1º Fast Axis
23.8° Slow Axis | Not known |
| Aiming Beam | Red aiming beam
laser class II | No aiming beam |
| Controls | Footswitch or
handswitch | Footswitch |
| Electrical
Requirements | 110-240 V5060
Hz,
110-230 V
Hz,
16 A (max. 1.75
kW) | 115 - 230 V ± 10% ~ 50 Hz / 60 Hz
10 A (max. 1.1 kW) |
| Power Calibration
Method | Diode current
calibrated by
external power
ruler | Diode current calibrated by external
power ruler |
| Sterilization
Aspects | Applicator is
disinfected
between patients. | Applicator is disinfected between
patients. |
| Pulse Formation | CW current
switched on / off | CW current switched on / off |
| Pulse Train
Duration | 4 ms - 100 ms | 6 ms - 60 ms |
| Beam Diameter | 1 mm x 15 mm | 1 mm x 12 mm |
| Duty Cycle | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."