. 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.

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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the InMode SR IPL Device based on the provided text:

Important Note: The provided 510(k) summary explicitly states "Clinical Performance Data: Not Applicable." This means no clinical study was conducted by InMode MD to demonstrate the device's efficacy or safety on human subjects for this submission. The device received clearance based on substantial equivalence to a predicate device, which is a common pathway for medical device approval. Therefore, many of the typical questions about study design, sample sizes, and ground truth generation will not be applicable in this context.

Acceptance Criteria and Device Performance

Since no clinical study was performed for this 510(k) submission, there are no specific performance-based acceptance criteria or reported device performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device (Sciton Profile BBL) and compliance with voluntary recognized standards.

Table of Acceptance Criteria (as demonstrated by substantial equivalence and standards compliance):

Acceptance Criterion	Reported Device Performance (as per comparison to predicate)
Intended Use Equivalence:
- Benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides/freckles)	InMode SR IPL device shares the same intended use as the predicate device.
- Benign cutaneous vascular lesions (port wine stains, telangiectasias, rosacea, angiomas, etc.)	InMode SR IPL device shares the same intended use as the predicate device.
Technological Characteristics Equivalence:
- Wavelength	InMode SR: 515-1200nm, 580-1200nm; Comparable to Profile BBL: 515-1400nm, 560-1400nm, 590-1400nm (within similar ranges).
- Energy Density (Fluence)	InMode SR: 10-30 J/cm²; Identical to Profile BBL: 10-30 J/cm².
- Pulse Duration	InMode SR: 5-30ms; Comparable to Profile BBL: 10-30ms (overlapping range).
- Pulse Repetition Rate	InMode SR: 1pps; Comparable to Profile BBL: Up to 1pps.
- Pulse Sequence	InMode SR: Single Pulse; Identical to Profile BBL: Single pulse.
- Delay between sub-pulses	InMode SR: N/A; Identical to Profile BBL: N/A.
- Spot Size	InMode SR: 10x30mm; Comparable to Profile BBL: 10x50mm maximal, 7mm round minimal (shows a similar range of applicability).
- Cooling Method	InMode SR: Contact Cooling (10°C-25°C); Comparable to Profile BBL: Contact Cooling (10°C-35°C) (both use contact cooling within a similar temperature range).
Safety and Performance Standards Compliance:
- Electrical Safety (IEC 60601-1)	Complies with IEC 60601-1.
- Electromagnetic Compatibility (IEC 60601-1-2)	Complies with IEC 60601-1-2.
- Programmable Electrical Medical Systems (IEC 60601-1-4)	Complies with IEC 60601-1-4.
- Non-Laser Light Source Equipment Safety (IEC 60601-2-57)	Complies with IEC 60601-2-57.
- Software Validation	Underwent software validation testing.
- Mechanical Safety Testing	Underwent mechanical safety testing.

Study Details (or lack thereof, as applicable):

Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set involving human subjects was used for this 510(k) submission. The device gained clearance through substantial equivalence to a predicate device and compliance with recognized standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical test set was created or used, there was no need for experts to establish ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set was used, so no adjudication method was employed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a medical device, specifically an IPL (Intense Pulsed Light) device. It is not an AI/software as a medical device (SaMD) that assists human readers in diagnosis. Therefore, no MRMC comparative effectiveness study was conducted with human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm. The device's performance is assessed by its physical specifications, safety, and equivalence to a predicate, not by algorithmic standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Since no clinical study was performed for this 510(k) submission, there was no ground truth established from expert consensus, pathology, or outcomes data for the InMode SR IPL device itself. The basis for clearance relies on the established safety and efficacy of the predicate device (Profile BBL) and the InMode SR's demonstrated equivalence to it.
The sample size for the training set:
- Not Applicable. As this is not an AI/machine learning device, there was no "training set" in the context of algorithm development.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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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 102Kfar Saba 44425Israel
	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 LIGHTDevice	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k)
৫Sciton	יחח .્રProfile	K032460A AND ALL AND A

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Device Description:

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:

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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 cutaneousvascular lesions, including portwine stains, facial, truncal and legtelangiectasias, rosacea, erythemaof rosacea, engiomas and spiderangiomas, poikiloderma of Civatte,superficial leg veins and venousmalformations	Treatment of benign cutaneousvascular lesions, including portwine stains, facial, truncal and legtelangiectasias, rosacea, erythemaof rosacea, engiomas and spiderangiomas, poikiloderma of Civatte,superficial leg veins and venousmalformations
Wavelength	515-1200nm580-1200nm	515-1400nm560-1400nm590-1400nm
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 roundminimal
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

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	1	CONSTITUTION	ANNUA A A B A Aמרצית 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 pigmentedlesions including dyschromia,hyperpigmentation, melasma,ephelides (freckles)	Treatment of benign pigmentedlesions including dyschromia,hyperpigmentation, melasma,ephelides (freckles)
Wavelength	515-1200nm580-1200nm	515-1400nm560-1400nm590-1400nm
Energy density	10-30 J/cm²	10-30 J/cm²
Pulse duration	5-30ms	10-30ms
Pulse repetitionrate	1pps	Up to 1pps
Pulse sequence	Single Pulse	Single pulse
Delay between sub-pulses	N/A	N/A
Spot size	10x30mm	10x50mm maximal, 7mm roundminimal
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

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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

Page 1 of 1

Regulation Number and Section

§ 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.