(87 days)
Not Found
No
The description focuses on laser technology, optical energy delivery, cooling systems, and user-adjustable parameters. There is no mention of AI, ML, or any features that suggest adaptive learning or data-driven decision making within the device's operation.
No.
The device is intended for hair removal and permanent hair reduction, which are cosmetic procedures, not a treatment for a disease or condition that would typically classify it as a therapeutic device.
No
The device is intended for hair removal and permanent hair reduction, which are therapeutic applications, not diagnostic ones.
No
The device description clearly outlines a physical system including a power supply, diode driver, water cooling system, controller, touch screen user interface, hand piece, cable, and foot switch. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "hair removal and permanent hair reduction." This is a cosmetic or therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a laser-based system that delivers optical energy to the skin. This is a physical intervention, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The InMode Diolaze XL System with the Diolaze XL 810mm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction is hair counts at 6, 9 or 12 months following a treatment regimen. The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The InMode Diolaze XL multisystem (manufactured by InMode MD Ltd.) is a laser based technology platform system utilizing different hand pieces for laser hair removal procedures. The Diolaze XL system was already FDA cleared in K170738 along with its designated Diolaze 810nm hand piece.
The InMode Diolaze XL System is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The handpiece has integrated skin cooling to enhance safety and comfort of the treatment.
The InMode Diolaze XL System consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode Diolaze XL System with 20 diode laser bars stacked vertically. The diode is enclosed to the sapphire light guide. The diode laser produces up to 3000W peak optical power.
The InMode Diolaze XL System utilizes three add-ons diode laser hand pieces:
- Diolaze 810nm Hand piece (FDA cleared in K170738)
- Diolaze 755/810nm Hand piece
- Diolaze 810/1064nm Hand piece.
Following are the InMode Diolaze XL System specifications:
Laser Output Parameters:
Wavelengths: 810 nm, 810/1064 nm, 755/810 nm
Fluence: 5-40 J/cm²
Pulse width (duration): 5-200 ms (pulse type : Short/Long)
Light guide cooling: Strong: 7°C, Normal: 12°C
Spot size: 11x 27.5 mm²
Dimension: 46cm W x 46cm D x 100cm H (18.2" W x 18.2" D x 40" H)
Weight: 32 Kg (70.548 lbs)
Main Line Frequency (nominal): 50-60 Hz
Input Voltage (nominal): 100-240 VAC
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
axilla, groin areas
Indicated Patient Age Range
18-65 years old
Intended User / Care Setting
Prescription Use
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)
A proscription, open labeled, multicenter, single arm Clinical study was conducted to evaluate the efficacy and safety of the InMode Diolaze XL System with the Diolaze 755/810nm and 810/1064nm hand pieces. The study performed on 31 female subjects, aged between 18-65 years old, comprise three consecutive hair removal laser treatment, 4 weeks apart, and a follow up visit scheduled 3months from last laser treatment. The subjects were treated on their axilla, and groin areas with either the 755/810nm hand piece or the 810/1064nm hand piece. The treatment area was photographed following treatment and at follow up visit. Photography hair counts were performed by three independent, blinded evaluators and a statistical comparison was conducted between baseline hair counts and 3 months follow up hair counts. Study results revealed that a significant reduction in hair count was demonstrated for both hand pieces and at both treatment areas. An average hair reduction of 49.2% was reached. No adverse events were reported in the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average hair reduction of 49.2%
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.
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 shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font. The logo is simple and professional, and it is easily recognizable.
June 14, 2018
InMode MD Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, ISRAEL 44425
Re: K180719
Trade/Device Name: InMode Diolaze 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: March 12, 2018 Received: March 19, 2018
Dear Amit Goren:
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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
InMode Diolaze XL System
Indications for Use (Describe)
The InMode Diolaze XL System with the Diolaze XL 810mm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction is hair counts at 6, 9 or 12 months following a treatment regimen. The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.
| 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
510(K) SUMMARY
INMODE DIOLAZE XL SYSTEM
510(k) Number K180719
Applicant Name:
| Company Name: | InMode MD Ltd. |
|---|---|
| Address: | Tabor Building, Shaar Yokneam |
| Yokneam 2069200 | |
| Israel | |
| Tel: | +972-4-9097470 |
| Fax: | +972-4-9097471 |
| E-mail: | amit@asteinrac.com |
Contact Person:
Official Correspondent: Amit Goren
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. | ||
|---|---|---|---|
| Address: | 20 Hata'as Str., Suite 102 | ||
| Kfar Saba 4442500 | |||
| Israel | |||
| Tel: | +972-9-7670002 | ||
| Fax: | +972-9-7668534 | ||
| E-mail: | amit@asteinrac.com | ||
| Date Prepared: | March 12, 2018 | ||
| Trade Name: | InMode Diolaze XL System | ||
| Classification Name: | CFR Classification section 878.4810; (Product code GEX) | ||
| Classification: | Class II Medical Device |
Predicate Device:
The InMode Diolaze XL System is substantially equivalent to the following predicate devices.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Asceplion Laser Technologies GmbH | MedioStar NeXT Family (ALX) | K143519 |
| InMode MD Ltd. | InMode Diolaze XL | K170738 |
| Lutronics Corp. | Advantage | K141555 |
4
Device Description:
The InMode Diolaze XL multisystem (manufactured by InMode MD Ltd.) is a laser based technology platform system utilizing different hand pieces for laser hair removal procedures. The Diolaze XL system was already FDA cleared in K170738 along with its designated Diolaze 810nm hand piece.
The InMode Diolaze XL System is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The handpiece has integrated skin cooling to enhance safety and comfort of the treatment.
The InMode Diolaze XL System consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode Diolaze XL System with 20 diode laser bars stacked vertically. The diode is enclosed to the sapphire light guide. The diode laser produces up to 3000W peak optical power.
The InMode Diolaze XL System utilizes three add-ons diode laser hand pieces:
- Diolaze 810nm Hand piece (FDA cleared in K170738)
- Diolaze 755/810nm Hand piece ●
- Diolaze 810/1064nm Hand piece .
Following are the InMode Diolaze XL System specifications:
| Laser Output Parameters: | |
|---|---|
| Wavelengths | 810 nm |
| 810/1064 nm | |
| 755/810 nm | |
| Fluence | 5-40 J/cm² |
| Pulse width (duration) | 5-200 ms (pulse type : Short/Long) |
| Light guide cooling | Strong: 7°C, Normal: 12°C |
| Spot size | 11x 27.5 mm² |
| Dimension: | 46cm W x 46cm D x 100cm H |
| (18.2" W x 18.2" D x 40" H) | |
| Weight: | 32 Kg (70.548 lbs) |
| Main Line Frequency (nominal): | 50-60 Hz |
| Input Voltage (nominal): | 100-240 VAC |
5
Intended Use/Indication for Use:
The InMode Diolaze XL System with the Diolaze XL 810mm Hand piece is intended 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 InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.
Performance Standards:
The InMode Diolaze XL System has been tested and complies with the following voluntary recognized standards:
- AAMI ANSI: ES 60601-1:2005/(R)2012 and A1:2012. C1:2009/(R)2012 . and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2007-03(Modified), 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 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 60825-1: Edition 2.0 2007-03, Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)].
Non-Clinical Performance Data:
The InMode Diolaze XL System laser output parameters were evaluated as part of the test performance evaluation conducted in adherence with the FDA recognized consensus standards 60601-1, 60601-1-2, 60601-2-22 and 60825-1. The results of these performance tests demonstrated that the InMode Diolaze XL System operates in accordance with the device design requirements and performs within the range of laser specifications as to that of the predicate devices and therefore, is substantially equivalent to the predicate devices. Additionally, the device SW was validated in accordance with the FDA recognized consensus standard IEC 62304:2004 to IEC 62304 — 2006/AC 2008.
Pre-Clinical Performance Data:
Not Applicable
6
Clinical Performance Data:
A proscription, open labeled, multicenter, single arm Clinical study was conducted to evaluate the efficacy and safety of the InMode Diolaze XL System with the Diolaze 755/810nm and 810/1064nm hand pieces. The study performed on 31 female subjects, aged between 18-65 years old, comprise three consecutive hair removal laser treatment, 4 weeks apart, and a follow up visit scheduled 3months from last laser treatment. The subjects were treated on their axilla, and groin areas with either the 755/810nm hand piece or the 810/1064nm hand piece. The treatment area was photographed following treatment and at follow up visit. Photography hair counts were performed by three independent, blinded evaluators and a statistical comparison was conducted between baseline hair counts and 3 months follow up hair counts. Study results revealed that a significant reduction in hair count was demonstrated for both hand pieces and at both treatment areas. An average hair reduction of 49.2% was reached. No adverse events were reported in the study.
Substantial Equivalence:
The following table presents a comparison between the subject device and its predicate devices:
| Technological
Characteristic | InMode Diolaze
XL System
InMode MD
Ltd. | InMode Diolaze
XL System
(InMode MD
Ltd.)
K170738 | Advantage
(Lutronics
Corp.)
K141555 | MedioStar, ALX
(Asceplion Laser
Technologies GmbH)
K143519 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code, Class | GEX,
Class II | GEX,
Class II | GEX,
Class II | GEX,
Class II |
| Indications
for Use | The InMode
Diolaze XL
System with the
Diolaze XL
810nm Hand
piece is intended
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. | Hair removal and
permanent hair
reduction defined
as the stable,
long-term
reduction in hair
regrowing when
measured at 6, 9,
or 12 months
after the
completion of
treatment regime. | Is intended
for hair
removal,
permanent
hair
reduction
(defined as
long term
stable
reduction in
the number
of hairs
regrowing
after the last
treatment
measured at
6,9 and 12
months | Hair removal and
permanent hair
reduction defined as
reduced growth with
or without
maintenance when
measured at 6, 9, or 12
months |
7
| Technological
Characteristic | InMode Diolaze
XL System
InMode MD
Ltd. | InMode Diolaze
XL System
(InMode MD
Ltd.)
K170738 | Advantage
(Lutronics
Corp.)
K141555 | MedioStar, ALX
(Asceplion Laser
Technologies GmbH)
K143519 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | Diolaze XL
System with the
Diolaze XL
755/810nm &
810/1064nm
Hand pieces is
intended for hair
removal. | | | |
| Target
Population | Subjects seeking
hair removal | Subjects seeking
hair removal | Subjects
seeking hair
removal | Subjects seeking hair
removal |
| Wavelength | 810 nm
810/1064 nm
755/810 nm | 810nm | 1064 nm | 755 nm, ALX (several
hand pieces are
available as an option
that are 755-950nm)) |
| Fluence | 5-40 J/cm² | 5-40 J/cm² | 5-100 J/cm² | Maximum fluence:
35 J/cm² |
| Pulse
duration | 5-200 msec | 5-200 msec | 5-400 msec | Max pulse duration:
400 msec |
| Cooling
temperature | Skin sapphire
cooling | Skin sapphire
cooling | Contact
cooling
chilled
compression
tip | Skin cooling: Contact
skin cooling by cold
aluminum probe
(chilled compression
tip). Integrated water
compressor cooling
system |
| Spot size | 11x27.5mm² | 11x27.5mm² | 10x10mm² | 13x10mm² |
The indications for use of the InMode Diolaze XL System are substantially equivalent to the indications for use of predicate devices and are identical to the indications for use of the InMode Diolaze XL device (cleared as 510 (k) 170738). The design and components in the InMode Diolaze XL System, including the console (with power supply, software, cooling system and touch screen user interface), the water-cooled hand piece connected to the console via a cable and the foot switch are identical to the design and components found in the InMode Diolaze device (cleared as 510 (k) 170738) and very similar to those of the predicate devices. The performance specifications (including wavelength, fluence, pulse width, spot size and cooling) in the InMode Diolaze XL System are very similar to the predicate devices. The safety features in the InMode Diolaze XL System are substantially equivalent to the safety features found in the predicate devices. Consequently, the InMode Diolaze XL System is substantially equivalent to the MedioStar NeXT Family (ALX) predicate device, cleared in 510(k) K143519, the InMode Diolaze XL System predicate device, cleared in 510(k) K170738,
8
and to the Advantage predicate device, cleared in 510 (k) K141555 and therefore, may be legally marketed in the USA.
Conclusions:
Based on the performance testing, clinical study and comparison to predicate devices, the InMode Diolaze XL System is as safe and effective as its predicate devices and consequently is substantially equivalent to the predicate devices listed above.