The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm):
The 515 - 1200 nm intense pulsed light wavelengths are indicated for:
The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae;
The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent , hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd: YAG laser is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including:
Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Real Time Chiller:
The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
Reduce discomfort during and/or associated with light or laser treatment;
Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Device Description

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components:
A light/laser system console (including software and control electronics);
A control and display panel;
One or two attached handpiece(s);
A skin cooling device integrated into the handpiece (on some handpieces);
A trigger button integrated into the handpiece;
A remote interlock connector (disables light/laser when treatment room door is opened).

AI/ML Overview

The provided text describes a 510(k) submission for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems, including the Real Time Chiller. This is a medical device submission, and the information presented here is typical of such submissions, which focus on demonstrating substantial equivalence to previously cleared devices (predicates) rather than establishing new performance criteria through de novo studies.

Therefore, the requested information regarding detailed acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device's performance metrics (like sensitivity, specificity, F1-score, or human reader improvement, standalone performance) is not directly present in this document. This submission is for a physical laser/light system, and its "performance" is primarily assessed against safety and effectiveness relative to its predicate devices through clinical data (for safety/effectiveness) and engineering specifications (for things like cooling).

However, I can extract the information related to safety and effectiveness demonstration for this type of device, which serves a similar purpose to "acceptance criteria met by study results" in the context of its regulatory clearance.

Here's a breakdown of what can be extracted and inferred from the text, formatted to match your request where possible, and noting where the information is not applicable or not provided for this type of device:

1. A table of acceptance criteria and the reported device performance

For a laser/light system, "acceptance criteria" and "reported device performance" are typically related to clinical safety and effectiveness and adherence to specifications.

Acceptance Criteria (Inferred from Regulatory Standard)	Reported Device Performance (Summary from Submission)
Safety and Effectiveness for Indications	Clinical data demonstrated that the Lumenis Family of IPL/Nd:YAG laser systems (1064 nm) are safe and effective for specific applications in general and plastic surgery, and dermatology.
Cooling System Performance	Performance data was provided to demonstrate that the Cooling Head integrated into the Treatment Head operates in accordance with its specifications.
Substantial Equivalence to Predicate Devices	The device was found substantially equivalent to predicate devices in terms of indications for use, design features, and similar functional features.
Specific Clinical Outcomes (e.g., hair reduction, lesion clearance)	The device effects stable long-term, or permanent, hair reduction in skin types I-V. Indicated for treatment and clearance of superficial and deep telangiectasias and reticular veins (0.1-4.0 mm diameter) of the leg.
Epidermal Cooling Efficacy	Real Time Chiller is indicated to reduce pain/discomfort, minimize thermal injury, allow higher fluences, and reduce side effects during light/laser treatment. (Implicitly, the provided data supports these claims).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Clinical data was provided to demonstrate that the Lumenis Family of IPL/Nd: YAG laser systems (1064 nm) are safe and effective..." However, it does not specify the sample size for this clinical data. It also does not specify the data provenance (country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For a physical device, "ground truth" establishment in the context of diagnostic algorithms is not typically a direct component of the regulatory submission in the way you've phrased it. Clinical studies would involve physician assessments of treatment outcomes, but the number and specific qualifications of assessors for "ground truth" are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. 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

This is not applicable to this device. The Lumenis system is a laser/light treatment device, not an AI-driven diagnostic or assistive imaging tool that involves "human readers" and "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to this device. It is a physical treatment device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the clinical data provided, the "ground truth" would be clinical outcomes data related to the indications for use (e.g., observed hair reduction, clearance of vascular or pigmented lesions, safety endpoints like adverse events or reduced thermal injury due to cooling). However, the specific methodology of how this outcomes data was collected and validated is not detailed.

8. The sample size for the training set

This is not applicable as this is not an AI/algorithm-driven device requiring a training set in that sense. Clinical data provided would be for demonstration of safety and effectiveness, similar to a "test set" for performance evaluation, but not for "training" an algorithm.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated in point 8.

Summary for this specific device (Lumenis IPL/Nd:YAG Laser System):

This 510(k) submission focuses on demonstrating substantial equivalence to existing predicate devices based on shared indications for use, design, and functional features. Additionally, clinical data was provided to support the safety and effectiveness of the IPL/Nd:YAG laser systems for their stated specific applications, and performance data was included for the integrated cooling head to show it meets specifications. The document does not provide the granular details often found in submissions for AI/ML-driven diagnostic devices regarding sample sizes, ground truth establishment, or reader studies.

Summary

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K020839 1/3

Attachment 25 OCT 11 2002 510(k) Summary Statement for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: YAG Laser Systems

I. General Information

Submitter:	Lumenis, Inc.2400 Condensa StreetSanta Clara, CA 95051
Contact Person:	Anne C WordenActing VP, Regulatory & QA
Summary Preparation Date:	March 11, 2002

II. Names

Device Names:	Lumenis Family of Intense Pulsed-Light (IPL) andIPL/Nd:YAG Laser Systems
Primary Classification Name:	Laser Powered Surgical Instrument (and Accessories)

III. Predicate Devices

ESC Medical Systems EpiLight (K991935, K994014); .
ESC Medical Systems MultiLight (K994014); ●
ESC Medical Systems Photoderm HR (K991935); ●
ESC Photoderm Nd: YAG Accessory (K980537); ●
ESC Photoderm PL (K960772); ●
ESC Photoderm VL (K950493);
. Candela SPTL-1e Pulsed Dye laser system (K011092);
. Candela Dynamic Cooling Devices (K001589, K951033);
MedArt 520 Cooling System (K000503);
OptoMed DermaCool Skin Cooling Device (K990417); and ●
Coherent Epidermal Chiller Tip (K960032).

IV. Product Description

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components:

A light/laser system console (including software and control electronics);
A control and display panel;
One or two attached handpiece(s);
A skin cooling device integrated into the handpiece (on some handpieces);
A trigger button integrated into the handpiece;
. A remote interlock connector (disables light/laser when treatment room door is opened).

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020839 2/3

V. Indications for Use

In addition, the Lumenis Family of IPL/Nd:YAG laser systems (1064 nm) is safe and effective when indicated for coagulation and hemostasis of vascular lesions and soft tissue, including, the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm diameter) of the leg.

The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling), to reduce discomfort during and/or associated with light or laser treatment, to minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation, to allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions). to reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions), and to protect the skin from thermal necrosis, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation.

VI. Rationale for Substantial Equivalence

The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems share the same general indications for use, and therefore is substantially equivalent for use in surgical, aesthetic and cosmetic applications to the ESC Medical Systems EpiLight intense pulsed light systems (K991935, K994014), the ESC Medical Systems MultiLight intense pulsed light systems (K994014), the ESC Medical Systems Photoderm HR intense pulsed light systems (K991935), the ESC Medical Systems Photoderm Nd:YAG Accessory (K980537), the ESC Medical Systems Photoderm PL intense pulsed light systems (K960772), the ESC Medical Systems Photoderm VL intense pulsed light system (K950493), the Candela SPTL-1e Pulsed Dye laser system (K011092), the Candela Dynamic Cooling Devices (K001589 & K951033), the MedArt 520 Cooling System (K000503), the OptoMed DermaCool System and Handpieces (K990417), and the Coherent Epidermal Chiller Tip (K960032). In addition, clinical data demonstrated that

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020839 3/3

the Lumenis Family of IPL/Nd:YAG laser systems (1064 nm) are safe and effective when indicated for use in specific applications in the medical specialties of general and plastic surgery, and dermatology.

VII. Safety and Effectiveness Information

Clinical data was provided to demonstrate that the Lumenis Family of IPL/Nd: YAG laser systems (1064 nm) are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology. Performance data was provided to demonstrate that the Cooling Head integrated into the Treatment Head of the delivery handpiece for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems operates in accordance with its specifications.

VIII. Conclusion

The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems were found to be substantially equivalent to the predicate ESC Medical Systems EpiLight intense pulsed light systems (K991935, K994014), the ESC Medical Systems MultiLight intense pulsed light systems (K994014), the ESC Medical Systems Photoderm HR intense pulsed light systems (K991935), the ESC Medical Systems Photoderm Nd:YAG Accessory (K980537), the ESC Medical Systems Photoderm PL intense pulsed light systems (K960772), the ESC Medical Systems Photoderm VL intense pulsed light system (K950493), the Candela SPTL-1e Pulsed Dye laser system (K011092), the Candela Dynamic Cooling Devices (K001589 & K951033), the MedArt 520 Cooling System (K000503), the OptoMed DermaCool System and Handpieces (K990417), and the Coherent Epidermal Chiller Tip (K960032). The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems shares similar indications for use, design features, and similar functional features as, and thus are substantially equivalent to, the currently marketed predicate devices.

Clinical data was provided to demonstrate that the Lumenis Family of IPL/Nd: YAG laser systems (1064 mm) are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 11 2002

Ms. Anne C. Worden Acting Vice President, Regulatory and Quality Assurance Lumenis. Inc. 2400 Condensa Street Santa Clara, California 95051

Re: K020839

Trade/Device Name: Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems and the Real Time Chiller Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 11, 2002 Received: July 15, 2002

Dear Ms. Worden:

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 such 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 mav 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/3/Picture/11 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings spread and head turned to the right.

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Page 2 – Ms. Anne C. Worden

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stupt Rworde

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2 Indications For Use Statement as Requested by FDA

510(k) Number (if Known): K020839

Device Name: Lumenis Family of Intense Pulsed-Light (IPL) Systems & Combination IPL Systems and Nd:YAG Laser Systems and the Real Time Chiller

Indications For Use:

ষ্ট

A Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm):
The 515 - 1200 nm intense pulsed light wavelengths are indicated for:
The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including ● warts, scars and striae;
The treatment of benign cutaneous vascular lesions, including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
. The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent , hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm):

The 1064 nm wavelength produced by the Nd: YAG laser is indicated for:

The coagulation and hemostasis of vascular lesions and soft tissue, including: .
- Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.

Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)
-------------------------------------------------------	--

Prescription Use(Per 21 CFR 801.109)
------------------------------------------	--

Division Signe Officer Use
Division of General, Restorativeand Neurological DevicesK020839	(Optional Format 1-2-96)

510(k) Submission: Lumenis Family 510(k) Number YAG Laser Systems	Attachment 2 - Page 1Page revised
-------------------------------------------------------------------	---------------------------------------

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K020839 510(k) Number (if Known):

Device Name: Lumenis Family of Intense Pulsed-Light (IPL) Systems & Combination IPL

Systems and Nd: YAG Laser Systems and the Real Time Chiller

Continued from Previous Page Indications For Use:

> Real Time Chiller:

The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior .. to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:

Reduce pain during and/or associated with light or laser treatment (via partial anesthesia . from cooling);
Reduce discomfort during and/or associated with light or laser treatment; .
Minimize thermal injury, including thermal necrosis, to non-target skin and skin . structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
. Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
Reduce potential side effects of light or laser treatments (such as for hair removal and the . treatment of vascular or pigmented lesions).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	OR Over-The-Counter Use

(Division Sign-Off)
Division of General, Restorative and Neurological Devices
(Optional Format 1-2-96)
510(k) Number	K020839

510(k) Submission: Lumenis Fanily of IPL & IPL Nd: Y AG Laser Systems

Attachment 2 - Page 2 Page revised

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.

Attachment 25 OCT 11 2002 510(k) Summary Statement for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: YAG Laser Systems

I. General Information

II. Names

III. Predicate Devices

IV. Product Description

V. Indications for Use

VI. Rationale for Substantial Equivalence

VII. Safety and Effectiveness Information

VIII. Conclusion

DEPARTMENT OF HEALTH & HUMAN SERVICES

OCT 11 2002

Attachment 2 Indications For Use Statement as Requested by FDA

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> Real Time Chiller:

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

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