AXIOM PULSED LIGHT SYSTEM

K062312 · General Project S.R.L. · GEX · Oct 16, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062312
• Device Name: AXIOM PULSED LIGHT SYSTEM
• Applicant: General Project S.R.L.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. It is intended for use in: - Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction - Treatment of mild to moderate inflammatory acne (acne vulgaris) . - Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafè-au-lait

Device Story

Axiom Intense Pulsed Light (IPL) system; emits light radiation (590-1200 nm) via handpiece with exchangeable lamp box. Operates via rapid power discharge from capacitors into a Xenon lamp. Used in clinical settings for hair reduction, acne treatment, and dermatological lesion management. System includes control panel and handpiece. Physician/clinician-operated. Output light energy targets specific skin structures to achieve therapeutic effects; clinical decision-making based on visual assessment of skin condition and hair type.

Clinical Evidence

No clinical data submitted. Bench testing only; substantial equivalence based on comparison to legally marketed predicate devices.

Technological Characteristics

IPL system; light range 590-1200 nm; capacitive discharge power source; Xenon lamp; handpiece with exchangeable lamp box; control panel interface. Class II device.

Indications for Use

Indicated for patients requiring removal of unwanted hair (all skin types), treatment of mild to moderate inflammatory acne (acne vulgaris), and treatment of benign pigmented epidermal and cutaneous lesions (warts, scars, striae, lentigines, nevi, melasma, cafè-au-lait).

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

• General Project's Flash1 (K022583)
• General Project's Med FlashII (K051508)
• Radiancy's SpaTouch (K020856)
• Lumenis' IPL Quantum SR (K020839)
• Novalis Medical's Clareon Pulsed Light System (K043319)
• Cynosure's Photosilk Plus (K041095)

Submission Summary (Full Text)

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K 062312

#### 510(k) Summary

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92

#### 1. General Information

Submitter:

General Project, S.r.I. Via della Gora 13/1-15/19 50025 Montespertoli, Florence ltaly

OCT 16 2006

Contact Person:

Cornelia Damsky CDI Regulatory Consultants 56 Westcott Road Stamford, CT 06902 Tel: [phone] [e-mail]

Summary Preparation Date:

July23, 2006

#### 2. Names

Proprietary Name: Common Name: Classification Name:

Axiom Intense Pulsed Light System IPL System Laser surgical instrument for use in General and Plastic Surgery and in Dermatology. Product Code: GEX, Panel 79

### 3. Legally Marketed Predicate Devices

General Project's Flash1 (K022583) General Project's Med FlashII (K051508) Radiancy's SpaTouch (K020856) Lumenis' IPL Quantum SR (K020839) Novalis Medical's Clareon Pulsed Light System (K043319) Cynosure's Photosilk Plus (K041095).

The AXIOM Intense Pulsed Light System is substantially equivalent to the Flash 1 and the MedFlash II manufactured by General Project, Montespertoli, Florence, Italy. The AXIOM Intense Pulse Light system shares the same indications for use and the same or similar technological characteristics including: controls and displays and light source.

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#### 4. Device Description

The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the The Axion Intense Fullood Eight Oyel Cyell is based on a quick power discharge of range from 590 mm to 1200 mm to 1200 mm handpiece. This generates a rapid and Capacitors in a Xenon ramp, mountou on a hanspires include the charge intense Fulsed Eight. The four philopal pairol panel, and a handpiece with exchangeable lamp box

#### 5. Intended Use

The Axiom Intense Pulsed Light System is intended for treatment of mild to moderate inflammatory acne (acne vulgaris), removal of unwanted hair from all skin types and to inflammatory ache (acho valgano), For reduction. The Axiom is also indicated for effect stable, forig-term or permanent half readerneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafè-au-lait

#### 6. Performance Data

0. Ferformance data is required for this Class II device nor requested by the Food and No performanos data is roquire Evaluation). A database search has been drug Administration (Onloo of BONee Effects of the device that is currently marketed.

No data submitted for section 807.92 6[(b)(1)(2)(3c). See attached documentation of adverse effects.]

#### Conclusion:

The AXIOM Intense Pulsed Light System is substantially equivalent to the Flash 1 and The AXIOM Intense Pulse Light System shares the same indications for Med Hash in: "The ARCH as the predicate Intense Pulsed Light Systems.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 6 2006

General Project, S.r.l % CDI Regulatory Consultants Ms. Cornelia Damsky 56 Westcott Road Stamford, Connecticut 06902

Re: K062312 Trade/Device Name: AXIOM Intense Pulsed Light System 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: August 4, 2006 Received: August 9, 2006

Dear Ms. Damsky:

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. Cornelia Damsky

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]. 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 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/industry/support/index.html.

Sincerely vours,

Kof
Mark N. Melkerson

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

Enclosure

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U.S. Food and Drug Ad

RESERVED RIGHTS

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# Indications for Use

510(k) Number (if known): K062312

Device Name: AXIOM Intense Pulsed Light System

Indications for Use:

The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. It is intended for use in:

- Removal of unwanted hair from all skin types and to effect stable long-term or • permanent, hair reduction
- Treatment of mild to moderate inflammatory acne (acne vulgaris) .
- Treatment of benign pigmented epidermal and cutaneous lesions including warts, � scars, striae, lentigines, nevi, melasma and cafè-au-lait

Prescription Use
(Part 21 CFR 801 Subpart D)

-

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRHA Office of Device Evaluation (ODE)

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

**510(k) Number** k062312