(109 days)
Not Found
No
The document describes a standard IPL device with adjustable parameters and cooling, with no mention of AI or ML in the device description, intended use, or specific sections for AI/ML mentions.
Yes
The device is indicated for the treatment of various benign pigmented epidermal lesions and benign cutaneous vascular lesions, which are therapeutic applications.
No
The device description focuses on delivering optical energy for treatment purposes of previously diagnosed conditions, not on identifying or diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a power supply, cooling system, controller, user interface with LCD screen, and an IPL hand piece with a flash lamp, reflector, and sapphire output window. This is not a software-only device.
Based on the provided information, the InMode SR IPL Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The InMode SR IPL Device delivers optical energy directly to the skin for therapeutic treatment of various skin conditions. It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use clearly describes treatments applied directly to the skin, not the analysis of in vitro samples.
- Device Description: The description details the components involved in generating and delivering light energy to the skin, not components for sample handling or analysis.
Therefore, the InMode SR IPL Device falls under the category of a therapeutic device that interacts directly with the patient's body, rather than an IVD device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The InMode SR IPL Device wavelengths (515-1200mm) are indicated for use for the following treatments:
- The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations.
Product codes
ONF
Device Description
The InMode SR IPL device is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between 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 hand piece has integrated skin cooling to enhance safety and comfort of the treatment.
The InMode SR IPL device consists of an AC/DC power supply unit, water cooling system, controller, user interface including a LCD screen and functional buttons and IPL hand piece. The IPL hand piece is connected to the console via a cable. The hand piece comprises a flash lamp, reflector, water flow tube and cooled sapphire output window (10 x 30 mm).
Following are the InMode SR IPL device specifications:
Wavelength: 515 - 1200 nm Energy Density (Fluence): 10-30 J/cm-Pulse Duration: 4-27 msec Pulse repetition rate: up to 1 Hz Spot/scan size: 10 x 30 mm Skin cooling: Continuous contact cooling
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (Epidermal, Cutaneous)
Indicated Patient Age Range
Not Found
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)
Non-Clinical Performance Data: Not Applicable
Clinical Performance Data: Not Applicable
The InMode SR IPL device underwent performance testing, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2 and safety and essential performance testing of non-laser light source equipment according to IEC 60601-2-57. These performance tests demonstrated that the minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns.
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.
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510(K) SUMMARY
INMODE SR DEVICE
510(k) Number K123860
Applicant Name:
| Company Name: | |
|---|---|
| Address: |
InMode M,D Ltd. Tavor Building, Shaar Yokneam Yokneam 20692 Israel Tel: +972-4-9097470 Fax: +972-4-9097471 E-mail: ahava@asteinrac.com
Contact Person:
Official Correspondent: Ahava Stein
| Company Name: | A. Stein – Regulatory Affairs Consulting Ltd. |
|---|---|
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 44425 | |
| Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: ahava@asteinrac.com |
Date Prepared: December 6, 2012
Trade Name: InMode SR IPL Device
Classification Name: CFR Classification section 878.4810; (Product code ONF)
Classification: Class II Medical Device
Predicate Device:
The InMode SR IPL device is substantially equivalent to the following predicate devices.
| Manufacturer
|
A MICH A LIGHT
Device | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) |
|------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ৫
Sciton | יחח .
્ર
Profile | K032460
A AND ALL AND A |
1
Device Description:
The InMode SR IPL device is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between 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 hand piece has integrated skin cooling to enhance safety and comfort of the treatment.
The InMode SR IPL device consists of an AC/DC power supply unit, water cooling system, controller, user interface including a LCD screen and functional buttons and IPL hand piece. The IPL hand piece is connected to the console via a cable. The hand piece comprises a flash lamp, reflector, water flow tube and cooled sapphire output window (10 x 30 mm).
Following are the InMode SR IPL device specifications:
Wavelength: 515 - 1200 nm Energy Density (Fluence): 10-30 J/cm-Pulse Duration: 4-27 msec Pulse repetition rate: up to 1 Hz Spot/scan size: 10 x 30 mm Skin cooling: Continuous contact cooling
Intended Use/Indication for Use:
The InMode SR IPL Device wavelengths (515-1200mm) are indicated for use for the following treatments:
- · The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- · The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations.
Performance Standards:
The InMode SR IPL Device has been tested and complies with the following voluntary recognized standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988; Amendment 1, 1991-11, Amendment 2, 1995
- IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility --Requirements and Tests
- IEC 60601-1-4 Medical electrical equipment -- Part 1-4:General requirements for safety -. Collateral Standard: Programmable electrical medical systems
- IEC 60601-2-57 standard; Medical Electrical Equipment Part 2-57: Particular . Requirements for the Basic Safety and Essential Performance of Non-Laser Light Source Equipment Intended for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use
Non-Clinical Performance Data:
2
Not Applicable
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The indications for use and technological characteristics of the InMode SR IPL device are substantially equivalent to the indications for use and technological characteristics of the Profile BBL device.
The design and components in the InMode SR IPL device, including the console (with power supply, software, cooling system and control and display panel) and the water-cooled hand piece (with cable and connector to console) are similar to the design and components found in the Profile BBL device.
The performance specifications (including wavelength, fluence, pulse duration, pulse repetition rate, spot size and cooling) in InMode SR IPL device are similar to performance specifications in the Profile BBL device.
| Device | InMode SR | Profile BBL |
|---|---|---|
| Company | InMode MD | Sciton |
| 510(k) No. | K123860 | K032460 |
| Intended Use | Treatment of benign cutaneous | |
| vascular lesions, including port | ||
| wine stains, facial, truncal and leg | ||
| telangiectasias, rosacea, erythema | ||
| of rosacea, engiomas and spider | ||
| angiomas, poikiloderma of Civatte, | ||
| superficial leg veins and venous | ||
| malformations | Treatment of benign cutaneous | |
| vascular lesions, including port | ||
| wine stains, facial, truncal and leg | ||
| telangiectasias, rosacea, erythema | ||
| of rosacea, engiomas and spider | ||
| angiomas, poikiloderma of Civatte, | ||
| superficial leg veins and venous | ||
| malformations | ||
| Wavelength | 515-1200nm | |
| 580-1200nm | 515-1400nm | |
| 560-1400nm | ||
| 590-1400nm | ||
| Energy density | 10-30 J/cm² | 10-30 J/cm² |
| Pulse duration | 5-30ms | 10-30ms |
| Pulse repetition rate | 1pps | Up to 1pps |
| Pulse sequence | Single Pulse | Single pulse |
| Delay between sub- | ||
| pulses | N/A | N/A |
| Spot size | 10x30mm | 10x50mm maximal, 7mm round |
| minimal | ||
| Cooling method | Contact Cooling (10°C-25°C) | Contact Cooling (10°C-35°C) |
Comparison Table 1 - Indication for Use Treatment of Vascular Lesions .
Comparison Table 2 - Indication for Use Treatment of Pigments Lesions
| 10.00 | Complete on and can and change and and and and | | A . Comments of the comments of the called of
and an annual procession and the first and succession of an and and and the collection and the color of the closes of the close | Comments of the American Company of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Com |
|-------|------------------------------------------------|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 041100 | | -FINA MOTOR, I' | |
| | 1 | CONSTITUTION | ANNUA A A B A A
מרצית שירות המידע שמועד הראשונה ארצות הראשונים של מיני ארצות הראשונים של מיני או שיינו או שיינו או שיינו או שיינו או שיינו או שיינו או שיינו או שיינו או שיינו או שיינו או שי | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| Company | InMode MD | Sciton |
|---|---|---|
| 510(k) No. | K123860 | K032460 |
| Intended Use | Treatment of benign pigmented | |
| lesions including dyschromia, | ||
| hyperpigmentation, melasma, | ||
| ephelides (freckles) | Treatment of benign pigmented | |
| lesions including dyschromia, | ||
| hyperpigmentation, melasma, | ||
| ephelides (freckles) | ||
| Wavelength | 515-1200nm | |
| 580-1200nm | 515-1400nm | |
| 560-1400nm | ||
| 590-1400nm | ||
| Energy density | 10-30 J/cm² | 10-30 J/cm² |
| Pulse duration | 5-30ms | 10-30ms |
| Pulse repetition | ||
| rate | 1pps | Up to 1pps |
| Pulse sequence | Single Pulse | Single pulse |
| Delay between sub- | ||
| pulses | N/A | N/A |
| Spot size | 10x30mm | 10x50mm maximal, 7mm round |
| minimal | ||
| Cooling method | Contact Cooling (10°C-25°C) | Contact Cooling (10°C-35°C) |
The safety features in the InMode SR IPL device are substantially equivalent to the safety features found in the predicate device. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new InMode SR IPL device underwent performance testing, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2 and safety and essential performance testing of non-laser light source equipment according to IEC 60601-2-57. These performance tests demonstrated that the minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the InMode SR IPL device is substantially equivalent to the predicate Profile BBL device and therefore, may be legally marketed in the USA.
Conclusions:
Based on the performance testing and comparison to predicate devices, the InMode SR IPL device is substantially equivalent to the predicate device listed above.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Letter dated: April 2, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Inmode MD, Limited % A. Stein-Regulatory Affairs Consulting, Limited Ms. Ahava Stein General Manager 20 Hata'as Street, Suite 102 Kfar Saba, Israel 44425
Re: K123860
Trade/Device Name: InMode SR IPL Device 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: ONF Dated: February 28, 2013 Received: March 07, 2013
Dear Ms. Stein:
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 practice, labeling, and prohibitions against misbranding and adulteration.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Ahava Stein
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Number: K123860
Device Name: InMode SR IPL Device
Intended Use Statement:
The InMode SR IPL Device wavelengths (515-1200nm) are indicated for use for the following treatments:
- . The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- The treatment of benign cutaneous vascular lesions, including port wine stains, . facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.
Prescription Use V (Per 21 C.F.R. 801 Subpart D) OR
Over-The-Counter Use (Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogdens 2013.03.27 17:05:37 -04'00' (Division Sign-Off) for MXM
Division of Surgical Devices 510(k) Number K123860
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