BEAMAX

K063249 · Medic Sharplight , Ltd. · GEX · Jan 17, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063249
• Device Name: BEAMAX
• Applicant: Medic Sharplight , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BEAMAX is intended for aesthetic and cosmetic use. The device is specifically indicated for removal of hair by using selective light energy.

Device Story

BEAMAX is a pulsed light system for hair removal. It applies thermal energy to human skin via a hand piece in contact mode. The device consists of a Man Machine Interface panel, an operating console, and a treatment hand piece. It uses a flash light source to deliver selective light energy to target tissue. Operated by professionals in a clinical setting, the device output is used to achieve hair removal. The device benefits patients by providing a cosmetic aesthetic treatment for hair reduction.

Clinical Evidence

Bench and clinical data were provided to demonstrate that the device meets required specifications. No adverse effects were detected.

Technological Characteristics

Pulsed light hair removal system. Operates in contact mode using a flash light source. System includes a Man Machine Interface panel, operating console, and treatment hand piece. Class II device.

Indications for Use

Indicated for aesthetic and cosmetic hair removal using selective light energy. Prescription use only.

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

• Lovely I (Aria) (K033946)

Submission Summary (Full Text)

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# K063249

# 510(k) Summary of Safety and Effectiveness (in.accordance to 21 CFR 807.87(h)

#### Device Name

Proprietary Device Name: BEAMAX

#### Establishment Name and Registration Number of Submitter

Name: Medic SharpLight Ltd. Registration: In process Submission contact: Dan Laor Sireni 6, Haifa 32972, Israel TEL: [phone]

#### Device Classification

Product Code: Regulation Number: Common Name: Classification Name:

GEX 878.4810 Pulsed light hair removal system Laser surgical instrument for use in general and plastic surgery and in dermatology. Class II

Regulatory class:

#### Reason for 510(k) Submission

Traditional 510(k) Submission

#### Identification of Legally Marketed Equivalent Devices

K033946 Lovely I (Aria)

## Device Description

The BEAMAX applies thermal energy to human skin tissue. The energy is transmitted from a flash light source. It is transmitted to the target tissue by a hand piece that is in contact with the skin (contact mode).

The device is constructed from a Man Machine Interface panel, an operating console, and a treatment hand piece.

### Indications for use

The BEAMAX is intended for aesthetic and cosmetic use. The device is specifically indicated for removal of hair by using selective light energy.

## Safety & Effectiveness

The device has been designed, verified and validated complying with the 21CFR 820.30 regulations. Bench and clinical data demonstrate that the BEMAX meets the required specifications. No adverse affects have been detected.

#### Substantial Equivalency

It is Medic SharpLight opinion that the BEAMAX is substantially equivalent in terms of safety and effectiveness to the predicate device.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol that resembles a stylized caduceus or a representation of human figures. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medic SharpLight Ltd. % Quasar Quality Ltd. Mr. Dan Laor Managing Director 6 Sireni Street Haifa 32972 Isreal

JAN 17 2007

Re: K063249 Trade/Device Name: BEAMAX 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: November 23, 2006 Received: December 1, 2006

Dear Mr. Laor:

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 - Mr. Dan Laor

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 yours

F-R

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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# Indications for Use

K063249 510(k) Number (if known):

BEAMAX Device Name:

Indications For Use: The BEAMAX is intended for aesthetic and cosmetic use. The device is specifically indicated for removal of hair by using selective light energy.

Prescription Use: YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use: NO (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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**510(k) Number** L063249