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) 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, melsma, 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) 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.
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.

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 hand-piece(s), which may have integrated skin cooling components.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific acceptance criteria and performance metrics for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

No acceptance criteria table or reported device performance: The document does not define specific performance metrics or thresholds for the device's efficacy or safety. It focuses on functional and design equivalence to a predicate device.
No sample size for test set or data provenance: There is no mention of a test set, its sample size, or the country of origin/retrospective/prospective nature of data.
No number or qualifications of experts for ground truth: Since there's no defined 'ground truth' or test set evaluation in this type of submission, expert involvement in this context is not applicable or stated.
No adjudication method: Adjudication methods are not discussed as they relate to validating a test set against a ground truth, which is absent here.
No multi-reader multi-case (MRMC) comparative effectiveness study: The document does not describe such a study or any effect sizes of human reader improvement with AI assistance, as the device is not an AI-assisted diagnostic tool.
No standalone (algorithm-only) performance data: The device is a physical laser system, not an algorithm. Standalone performance as an algorithm is not relevant.
No type of ground truth used: As there's no defined test set for performance evaluation, there's no mention of a ground truth type (e.g., pathology, outcomes data).
No sample size for the training set: The document doesn't discuss a "training set" in the context of machine learning, as this device is not an AI/ML product.
No information on how ground truth for the training set was established: This is not applicable for the reasons mentioned above.

The document states the following regarding "Safety and Effectiveness Information":

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

However, the details of this "clinical data," including acceptance criteria, study design, sample sizes, and specific performance outcomes, are not provided in this summary. The primary basis for clearance is demonstrating "substantial equivalence" to a predicate device (K020839), rather than presenting a de novo study proving novel performance against predefined criteria.

In summary, the provided text describes a 510(k) submission for substantial equivalence of a physical medical device (laser system) and does not contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) typically associated with performance studies for novel or AI/ML-based devices.

Summary

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Summary
KC30342 1/3

JUL 17 2003

Submitter:	Lumenis, Inc.2400 Condensa StreetSanta Clara, CA 95051
Contact Person:	Andrea L. Ruth,Senior Associate, Regulatory Affairs
Summary Preparation Date:	January 31, 2003
Names
Device Names:	Lumenis Family of Intense Pulsed-Light (IPL) andIPL/Nd:YAG Laser Systems
Primary Classification Name:	Laser Powered Surgical Instrument (and Accessories)

Product Description III.

General Information

II.

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 hand-piece(s), which may have integrated skin cooling * components.

IV. Indications for Use

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.

Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm) are indicated for:

The treatment of tattoos and benign pigmented epidermal and cutaneous lesions * including warts, scars and striae;

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K030342

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 * permanent2, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

Nd:YAG Laser Wavelength (1064 nm) 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.
The removal of unwanted hair from all skin types, and to effect stable long-term, * or permanent2, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

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 hyperand/or complications such as scabbing, scarring, possible 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).

V. Rationale for Substantial Equivalence

The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: Y AG laser systems share the same general indications for use, and therefore is substantially equivalent for use in surgical, aesthetic and cosmetic applications to the previously cleared IPL and IPL/Nd:YAG family.

VI. Safety and Effectiveness Information

Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective, when indicated in

2 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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Ko 30342 >/ 3

specific applications in the medical specialties of general and plastic surgery, and dermatology.

VII. Conclusion

The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems were shown to be substantially equivalent to the predicate devices cleared in K020839. The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems has identical intended use, as well as functional and design features as the currently marketed predicate devices. The only change is expansion of labeled indications for use, which fall within the scope of the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUL 17 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Andrea L. Ruth Senior Associate, Regulatory Affairs Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051

Re: K030342 Trade/Device Name: Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 12, 2003 Received: May 13, 2003

Dear Ms. Ruth:

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 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); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Andrea L. Ruth

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), 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) you may obtain. 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,

Miriam C. Provost

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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K630342 510(k) Number (if Known):

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Device Name: Laser Systems

Indications For Use:

Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm) 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, melsma, 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 * permanent3, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

Nd:YAG Laser Wavelength (1064 nm) 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.
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent3, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

*** Continued on Following Page ***

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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

LUMENIS, INC. MODIFICATION TO IPL AND IPL/ND:YAG COMBINATION PRODUCT FAMILIES CONFIDENTIAL

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510(k) Number (if Known):

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Device Name: Laser Systems

*** Continued from Previous Page ***

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; 关
- 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).

Muriam C. Provost

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K030342

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

510(k) Number -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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Over-The-Counter Use OR

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

LUMENIS, INC. MODIFICATION TO IPL AND IPL/ND:YAG COMBINATION PRODUCT FAMILIES CONFIDENTIAL

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.