MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS

K024093 · Lumenis, Ltd. · GEX · Jun 19, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024093
• Device Name: MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS
• Applicant: Lumenis, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 19, 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

Lumenis IPL and IPL/Nd:YAG systems utilize coherent and non-coherent light energy for selective photothermolysis and hemostasis. System components include a console with control electronics/software, display panel, and hand-pieces with integrated skin cooling. Operated by clinicians in medical settings. The Real Time Chiller provides epidermal cooling before, during, and after treatment to mitigate thermal injury and patient discomfort, enabling higher fluence application. Output is delivered via hand-piece to target soft tissue, vascular lesions, or hair follicles. Clinical benefit includes effective treatment of dermatological conditions and aesthetic improvements with reduced side effects through thermal management.

Clinical Evidence

Clinical data provided to demonstrate safety and effectiveness for indicated applications in general surgery, plastic surgery, and dermatology. No specific study metrics (e.g., p-values, sensitivity) provided in summary; evidence supports substantial equivalence to predicate devices.

Technological Characteristics

System utilizes IPL (515-1200 nm) and Nd:YAG (1064 nm) laser energy. Fluence up to 150 J/cm², pulse duration 2-16 ms (up to 48 ms triple pulsed), spot size 6mm. Features integrated skin cooling hand-pieces. Console-based system with control electronics and software. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for surgical, aesthetic, and cosmetic applications requiring selective photothermolysis and hemostasis of soft tissue in general surgery, plastic surgery, and dermatology. IPL (515-1200 nm) indicated for: tattoos, benign pigmented epidermal/cutaneous lesions (warts, scars, striae), benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, melasma, angiomas, poikiloderma of Civatte, leg veins, venous malformations), and hair removal/reduction (skin types I-VI). Nd:YAG (1064 nm) indicated for: coagulation/hemostasis of vascular lesions/soft tissue (telangiectasias, reticular veins 0.1-4.0 mm) and non-ablative facial wrinkle treatment. 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)
• Lyra™ (K020021)
• GentleYAG™ (K022951)

Submission Summary (Full Text)

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Traditional Pre-market Notification K024093 Additional Information March 13, 2003

## JUN 1 9 2003

# 510(k) Summary

| 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 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; Lyra™; GentleYAG™ |
| Predicate Device<br>Manufacturer(s) | Lumenis; Lumenis; LaserScope; Candela |
| Predicate Device Reference(s) | K020839; K020839; K020021; K022951 |
| Predicate Device Classification<br>Name(s) | Laser Surgical Instrument for Use in General and Plastic Surgery<br>and in Dermatology |
| Predicate Device<br>Classification(s) | 21 CFR §878.4810 |

### Table 1 - Administrative Information

Date Summary Was Prepared: March 13, 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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KOJ4093 1/2

Traditional Pre-market Notification K024093 Additional Information March 13, 2003

| Predicate Device | This device | Lumenis VascuLight<br>or IPL Quantum Families | Laserscope Lyra™ | Candela<br>GentleYAG |
|---------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------|--------------------------------------------------|
| 510(k)<br>Reference | Current<br>submission | K020839 | K020021 | K022951 |
| Intended Use | Photocoagulation,<br>photothermolysis<br>and hemostsis<br>See indications for<br>use statement | Photocoagulation,<br>photothermolysis and<br>hemostsis | Treatment of facial<br>wrinkles | Treatment of<br>facial wrinkles |
| Device<br>Description | IPL and<br>IPL/Nd:YAG<br>combination | Same | Nd:YAG | Nd:YAG |
| Output Energy<br>Used | Coherent and non-<br>coherent light | Same | Same | Same |
| Energy<br>Configuration | 515 - 1200 nm<br>1064nm | Same | 1064 nm | 1064 nm |
| Fluence | Up to 150 J/cm² | Same | Up to 250 J/cm² | 10 to 70 J/cm² |
| Pulse | 2 to 16 ms<br>(to 48 ms triple<br>pulsed) | Same | 10 to 50 ms | 3 ms |
| Pulse Rate | 0.33 Hz | Same | 1-10 pps | 1 Hz |
| Spot Size | 6mm | Same | 3mm, 5mm,<br>10mm | 12 mm |
| Beam Delivery | Cooling Hand-<br>piece | Same | Fiber w/cooling<br>aiming beam<br>sapphire crystal | Lens-coupled<br>optical fiber with<br>hand-piece |
| Electricity | 115/230V | Same | 115/230V | 230V |
| Simultaneous<br>Delivery? | No | No | No | No |
| Single Use? | No | No | No | No |
| Sterilized? | No | No | No | No |
| Manufacturer | Lumenis | Lumenis | LaserScope | Candela |
| Device<br>Classification | II; 21 CFR §<br>878.4810, GEX | II; 21 CFR §<br>878.4810, GEX | II; 21 CFR §<br>878.4810, GEX | II; 21 CFR §<br>878.4810, GEX |

#### Table 2 - Comparison to Predicate Devices:

Summary of the Clinical Data: 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.

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2003

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

Re: K024093 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: March 13, 2003 Received: March 21, 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, 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,

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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#### Attachment 2 Indications for Use Statement as Requested by FDA

510(k) Number (if Known): K024093

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

Indications For Use:

The Lumenis Family of Intense Pulsed-Light (IPL) systems and combination 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 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 permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles;

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

*** Continued on Following Page ***

(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 (Optional Format 1-2-96)

LUMENIS, INC. MODIFIED IPL AND IPLAND: YAG COMBINATION PRODUCT FAMILIES

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510(k) Number (if Known):

K024093

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

Indications For Use: *** Continued from Previous Page ***

Nd:YAG Laser Wavelength (1064 nm):

- * 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 non-ablative treatment of facial wrinkles.

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, hyperand/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 |
|--------------------------------------------|----------------------|
| Miriam C. Provost | |
| Division Sign-Off (Optional Format 1-2-96) | |

eral, Restorative

LUMENIS, INC.

CONFIDENTIAL.

THE AND IPL/ND:YAG COMBINATION PRODUCT FAMILIES
CONFIDENTIAL
510(k) Number K 624093