LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS

K030527 · Lumenis · GEX · May 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030527
• Device Name: LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
• Applicant: Lumenis
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 intended 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.

Device Story

System consists of console (electronics/software), control panel, and hand-pieces with integrated skin cooling. Uses Intense Pulsed Light (515-1200 nm) and Nd:YAG laser (1064 nm) to deliver energy for selective photothermolysis and hemostasis. Operated by clinicians in general surgery, plastic surgery, or dermatology settings. Real Time Chiller cools epidermis before, during, and after treatment to mitigate thermal injury and patient discomfort. Output allows clinicians to perform aesthetic/surgical procedures; clinical benefit includes effective treatment of vascular/pigmented lesions and hair reduction with reduced side effects.

Clinical Evidence

Clinical data provided to demonstrate safety and effectiveness for indicated uses in general surgery, plastic surgery, and dermatology. No specific study metrics (e.g., sensitivity, AUC) provided in summary.

Technological Characteristics

System includes console, control panel, and hand-pieces with integrated cooling. Energy sources: Intense Pulsed Light (515-1200 nm) and Nd:YAG laser (1064 nm). Features include software-controlled electronics for energy delivery and epidermal cooling. Connectivity and specific software architecture not detailed.

Indications for Use

Indicated for patients requiring treatment of tattoos, benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides), cutaneous lesions (warts, scars, striae), benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma of Civatte, leg veins, venous malformations), and hair removal/reduction (skin types I-V). Nd:YAG component indicated for coagulation/hemostasis of vascular lesions and soft tissue, including leg telangiectasias and reticular veins (0.1-4.0 mm). Real Time Chiller indicated for epidermal cooling to reduce pain/discomfort, minimize thermal injury, and allow higher fluences.

Regulatory Classification

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.

Predicate Devices

• IPL Quantum Family (K020839)
• VascuLight Family (K020839)

Submission Summary (Full Text)

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K0305627

# MAY 2 0 2003

#### Appendix 2 VIII.

## A. 510(k) Summary

## Table 1 - Administrative Information

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| Category: | Comments |
|--------------------------------------------|-----------------------------------------------------------------------------------------|
| Sponsor: | Lumenis, Inc.<br>2400 Condensa Street<br>Santa Clara, CA 95051 |
| Correspondent: | Andrea L. Ruth, RAC<br>Senior Associate II, Regulatory Affairs |
| Contact Numbers: | 408.764.3235 |
| Device Common Name | Laser Powered Surgical Instrument (and Accessories) |
| Device Proprietary Name | Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG<br>Laser Systems |
| Device Classification Name | Laser Surgical Instrument for Use in General and planstic<br>Surgery and in Dermatology |
| Device Classification | 21 CFR § 878.4810 |
| Predicate Devices | IPL Quantum Family; VascuLight Family |
| Predicate Device<br>Manufacturer(s) | Lumenis |
| Predicate Device Reference(s) | K020839 |
| Predicate Device Classification<br>Name(s) | Laser Surgical Instrument for Use in General and planstic<br>Surgery and in Dermatology |
| Predicate Device<br>Classification(s) | 21 CFR §878.4810 |

Date Summary Was Prepared: February 15, 2003.

Description of the Device: 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; and
- * One or more attached hand-piece(s), which may have integrated skin cooling components.

Intended 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 intended 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.

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Kozo iji) 2/2

Traditional 510(k) Submission February 14, 2003

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 for their intended and indicated uses in the medical specialties of general and plastic surgery, and dermatology.

Conclusion: The Lumenis Family of Intense Pulsed-Light (IPL) and IPL / Nd: Y AG 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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 0 2003

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

Re: K030527

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: February 14, 2003 Received: February 19, 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 (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.

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Page 2 - Ms. Andrea L. Ruth, RAC

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Muh M. Milsener

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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## 510(k) Number (if Known): K030527

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

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 as follows:

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

- The treatment of tattoos; 关
- The treatment of benign pigmented epidermal lesions including dyschromia, * hyperpigmentation, melasma, ephelides(freckles);
- * The treatment of 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, erythema of rosacea, 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 permanent1, hair reduction in skin types I-V.

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

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">✓</div> | OR Over-The-Counter Use<br>(Optional Format 1-2-96) | |
|------------------------------------------|-----------------------------------------|-----------------------------------------------------|--|
|------------------------------------------|-----------------------------------------|-----------------------------------------------------|--|

1 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): K030527

Device Name:

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

### *** Continued from Previous Page ***

JAII CHILIS INC

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 permanent1, 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 complications such as scabbing, scarring, hyperand/or 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).

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------|
| Prescription Use | <img alt="line" src=""/> |
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | <img alt="line" src=""/> |
|--------------------------|--------------------------|
| (Optional Format 1-2-96) | |

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