NLITE SYSTEM,MODEL A00-1051

K020729 · Icn Photonics , Ltd. · GEX · Jun 4, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020729
• Device Name: NLITE SYSTEM,MODEL A00-1051
• Applicant: Icn Photonics , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NLite System laser system is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Vascular lesions, such as : Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.

Device Story

NLite System is a flashlamp-pumped, pulsed dye laser. Components include main console (laser resonator, high voltage delivery, internal cooler, fluid circulation, control unit, user interface), flexible fiber optic delivery device, optical handpiece, and footswitch. Operated by clinicians in dermatology/plastic surgery settings. Device delivers laser energy to target vasculature in dermal skin layers; induces permanent vascular damage. Clinical benefit includes treatment of vascular and benign cutaneous lesions. No clinical data provided; equivalence established via technological comparison to predicate pulsed dye lasers.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological design and identical physiological interactions compared to predicate devices.

Technological Characteristics

Flashlamp-pumped, pulsed dye laser. System includes laser resonator, high voltage delivery, internal cooler, fluid circulation, control unit, user interface, fiber optic delivery, and optical handpiece. Operates as a laser surgical instrument (Product Code GEX).

Indications for Use

Indicated for patients requiring treatment of vascular lesions (e.g., port wine stains, telangiectasia, leg/spider veins, spider naevus, poikiloderma of civatte, hemangiomas, angiomas, rosacea) and benign cutaneous lesions (e.g., scars, striae, psoriasis, verrucae vulgaris, warts) in dermatology and plastic surgery.

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

• Candela Clearbeam Pulse Dye Laser System (K013043)
• Cynosure Photogenica V Pulsed Dye Laser (K921842)

Submission Summary (Full Text)

{0}------------------------------------------------

JUN 0 4 2002

510(k) Submission for the ICN Photonics Ltd., Nlite System

IBNE

ICN Photonics Ltd.

# 510(k) Summary Statement. ICN Photonics Ltd., Nlite System

K020729

# 1. General Information.

| Submitter: | ICN Photonics Ltd<br>Units 1 & 2 Heol Rhosyn<br>Dafen Parc,<br>Llanelli,<br>Carmarthenshire,<br>Wales,<br>UK, SA14 8QG |
|------------|------------------------------------------------------------------------------------------------------------------------|
|------------|------------------------------------------------------------------------------------------------------------------------|

Contact : Ian Mortimer - Regulatory and Quality Manager.

Summary Preparation date : 28 Feb 2002

### 2. Names :

Device Name : Nite System

Primary Classification Name : Laser Powered Surgical Instrument.

# 3. Predicate Devices :

K013043 - Candela Clearbeam Pulse Dye Laser System K921842 - Cynosure. Photogenica V Pulsed Dye Laser.

# 4. Product Description

The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:

- Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
- Flexible fibre optic delivery device and optical handpiece; .
- Footswitch for pulsing control. .

{1}------------------------------------------------

510(k) Submission for the ICN Photonics Ltd., Nlite System

020729 2/2

IGN

ICN Photonics Ltd.

### 5. Indications for Use

The NLite system is indicated for use in the specialties of Dermatology and Plastic Surgery applications, and in particular for the treatment of Vascular lesions, such as Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea

And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.

### 6. Rationale for Substantial Equivalence

The key laser parameters, namely wavelength, pulse duration, energy density and delivery mechanism, produced by the NLite System are equivalent to both the predicate devices. The specific indications for use for the NLite System are identical that of the predicate. There is an identical interaction in the specific targeting of the Vasculature within the dermal region of the skin. The predicate devices are intended to produce permanent damage to the vasculature as is the NLite System.

As far as technological considerations are concerned, the NLite System utilizes the same design principles as the predicate devices, namely the method of producing the laser output is identical. More specifically, the laser output parameters and delivery method are equivalent in nature to those provided by the predicate devices.

#### 7. Safety and Efficacy Information

None required -- The precise equivalence to predicate devices negate the need to support additional efficacy information.

#### 8. Conclusion

The NLite System has been found to be substantially equivalent to the predicate devices, specifically in technological design resulting in identical desired physiological interactions. The design and manufacture of the device is in accordance with the relative international standards and the potential risk to operator and patient has been minimized.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ian Mortimer Regulatory and Quality Manager ICN Photonics Ltd. Units 1 & 2 Heol Rhosyn Dafen Parc Llanelli. Carmarthenshire Wales United Kingdom, SA14 8QG

JUN 0 4 2002

Re: K020729 Trade/Device Name: ICN Photonics Ltd. NLite System 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: February 28, 2002

Dear Mr. Mortimer:

Received: March 6, 2002

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. Iisting 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.

{3}------------------------------------------------

## Page 2 - Mr. Ian Mortimer

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.

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 [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), 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 vours.

Dr. Mark N. Millburn

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

{4}------------------------------------------------

510(k) Submission for the ICN Photonics Ltd., NLite System

IGN

ICN Photonics Ltd.

# Section 4 Indications for Use Statement as Requested by FDA

510(k) Number (if known): K020729

Device Name: ICN Photonics Ltd., NLite System

### Indications for Use:

The NLite System laser system is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Vascular lesions, such as : Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea

And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.

#### (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)

Section 4 14.02.01

OR
for Mark N. Mullaneon
Division Sign-Off
Over-The-Counter Use

vision of General. Restorative

510(k) Number ***_***K02729

- 1 -