CHROMOLITE SYSTEM

K053324 · Chromogenex Plc · GEX · Jan 5, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053324
• Device Name: CHROMOLITE SYSTEM
• Applicant: Chromogenex Plc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Chromolite™ System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialities of plastic surgery and dermatology as follows: The treatment of moderate inflammatory acne vulgaris . The treatment of benign pigmented epidermal lesions . including dyschromia, hyper-pigmentation, 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 leq telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations. The removal of unwanted hair and to effect stable long-. term or permanent hair reduction.

Device Story

Chromolite System is an Intense Pulsed Light (IPL) device; utilizes xenon flashlamp technology to deliver light-based therapy. Emits light at 390nm–1200nm via 50mm x 15mm waveguide; repetition rate 0.5Hz. Used in clinical settings by medical professionals (plastic surgery/dermatology) for selective photothermolysis, photocoagulation, and hemostasis. Device illuminates dermis to treat acne, pigmented/vascular lesions, cutaneous lesions, and unwanted hair. Healthcare provider operates device to target specific tissue; output is light energy; clinical decision-making based on visual assessment of skin condition. Benefits include non-invasive treatment of aesthetic/cosmetic conditions and long-term hair reduction.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Intense Pulsed Light (IPL) system; xenon flashlamp technology; 390nm–1200nm wavelength range; 50mm x 15mm waveguide; 0.5Hz repetition rate. Complies with European Medical Directive 93/42/EEC and UL60601-1:1996.

Indications for Use

Indicated for Fitzpatrick skin types I-V for treatment of moderate inflammatory acne vulgaris, benign pigmented epidermal lesions (dyschromia, hyper-pigmentation, 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 permanent hair reduction.

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

• Orion lasers, Lovely system II (Harmony) (K033946)

Submission Summary (Full Text)

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| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chromolite™ System | |
| 510(k) Number K 053324 | |
| Applicant: | Chromogenex Plc. |
| Address: | Units 1 & 2 Heol Rhosyn<br>Parc Dafen<br>Llanelli<br>Carmarthenshire<br>S. Wales<br>SA14 8QG<br>UK |
| Contact Person: | Mr. Chris Williams, Product Development Director |
| Telephone: | [phone] |
| Fax: | [phone] |
| Date prepared: | July 2005 |
| Device Trade Name: | Chromolite™ System |
| Common Name: | Intense Pulsed Light (IPL) |
| Classification Name: | Laser Surgical Instrument 21 C.F.R § 878.4810. |
| Product Classification: | Class II device. |
| Product Code: | GEX |
| Legally Marketed Predicate Device: | The Chromolite™ System is substantially equivalent in terms of<br>technological characteristics, performance, intended use,<br>indications for use and operator interface to;<br><br>• Orion lasers, Lovely system II (Harmony) (K033946) |
| System Description: | The Chromolite™ is a Intense Pulsed Light-based medical device<br>utilising xenon flashlamp technology to illuminate the dermis to<br>offer light based therapies as listed in the indications of use. The<br>Chromolite™ emits light at 390nm to 1200nm via a 50mm x 15mm<br>waveguide at a repetition rate of 0.5Hz. |
| Performance Standards: | The device complies with the European Medical Directive<br>93/42/EEC concerning medical devices, and will comply with<br>voluntary standards UL60601-1:1996 when marketed in the U.S. |

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K0 53324 2/2

- Indications for use: The Chromolite™ System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:
- The treatment of moderate inflammatory acne vulgaris .
- The treatment of benign pigmented epidermal lesions . including dyschromia, hyper-pigmentation, 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 leq telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
- The removal of unwanted hair and to effect stable long-. term or permanent hair reduction.

1 = Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment reqimen.

- Conclusion: The Chromolite system is substantially equivalent to its predicate device cited above, and raises no new safety and/or efficacy issues.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 JAN 5

Chromogenex Plc c/o Marc M. Mouser Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, Washington 98607

Re: K053324

Trade/Device Name: Chromolite System Regulation Number: 21 CFR 878.4810 Regulation Name: 21 CFX 078-1010
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 21, 2005 Received: December 22, 2005

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section >10(x) prematice names in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard mannent date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encentance with the provisions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not requent appro to the general controls provisions of the Act. The 1 ou may, dicierole, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 IT your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations with may be subject to sach additions. Title 21, Parts 800 to 898. In addition. FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 losaanse over device complies with other requirements of the Act that 117A has made a determinations administered by other Federal agencies. You must of any it cachar statutes and regulations and limited to: registration and listing (21 comply with an the Fer 816 creations)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It I art 607), laboring (27 OFF regulation (21 CFR Part 820); and if applicable, the electronic torth in the quanty systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Marc M. Mouser

This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you'ls ough mating of substantial equivalence of your device to a legally prematics notification: 11.0 12.01.2017 11:20:53 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 If you desire specific advice for Jour as 101) 276-0115. Also, please note the regulation entitled, comater the Oriece of Companise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## chror

## Indications for Use

510(k) Number (if known):

Device Name: Chromolite system

Indications for Use for Fitzpatrick skin types (I to V)

- The treatment of moderate inflammatory acne vulgaris .
- 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, erythema of rosacea, nomangiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
- The removal of unwanted hair and to effect stable long-term or permanent hair . reduction.

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

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | x |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

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NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

Page 1 of

(Division Sign-Of Division of General, Restorative, and Neurological De

510(k) Number K053324