MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS

K050950 · Active Optical Systems, Ltd./Efraim Bidas · GEX · Apr 29, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050950
• Device Name: MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
• Applicant: Active Optical Systems, Ltd./Efraim Bidas
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Crystal, Record & Optima are generally intended for dermatological use. The device is specifically indicated for removal of hair by using selective light energy.

Device Story

The Crystal, Record, and Optima are pulsed light hair removal systems. The device delivers photothermal energy to human skin tissue via a treatment handpiece in contact with the skin. This energy targets hair follicles to effect structural changes. The system is intended for dermatological use by healthcare professionals. It operates as a prescription-use device to achieve hair removal through selective light energy application.

Clinical Evidence

Bench and clinical data were provided to demonstrate that the devices meet required specifications. No adverse effects were reported.

Technological Characteristics

Pulsed light hair removal system; utilizes photothermal energy transmitted via a treatment handpiece in contact with skin. Designed in accordance with 21 CFR 820.30.

Indications for Use

Indicated for hair removal using selective light energy in dermatological applications.

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

• SkinStation (K030897)
• StarLux (K033549)

Submission Summary (Full Text)

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## APR 2 9 2005

# K 050950

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

Device Name

Device Name: Various models of the Crystal family photoepilation system. Trade / Proprietary Device Name: Crystal-512 Record-618 Optima-518

## Establishment Name and Registration Number of Submitter

Name: Active Optical Systems Ltd. In process Registration Number: Contact person: Efraim Bidas or Gil Bidas Address: 24 Herzel st. Petach Tikva, Israel Tel: ++97239341682 Fax: ++97239302888

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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. (21 CFR 878.4810) Class II

## Reason for 510(k) Submission

Regulatory class:

Traditional 510(k) Submission

## Identification of Legally Marketed Equivalent Devices

SkinStation K030897, StarLux K033549

## Device Description

The Crystal & Record are two models of the same device. The Optima is an additional commercial name of the Record. The device applies photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a light source to the target tissue by a Treatment Handpiece that is in contact with the skin.

## Indications for use

The Crystal, Record & Optima are generally intended for dermatological 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 to 21CFR 820.30 regulations. Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications. No adverse affects have been detected.

## Substantial Equivalency

It is Active Optical Systems' opinion that the Crystal, Record & Optima are substantially equivalent in terms of safety and effectiveness to the predicate devices.

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APR 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Active Optical Systems, Ltd. C/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K050950

Trade/Device Name: Crystal, Record & Optima 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: April 12, 2005 Received: April 15, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) fe device is substantially equivalent (for the indications ferenced above and nave decembers and marketed predicate devices marketed in interstate for use stated in the enclosure) to legars nament date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recure approval of a premarket approval application (PMA). alle Costience Act (11ct) that as novice, subject to the general controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of gencral 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), If your device is elassified (bee ass es) arols. Existing major regulations affecting your device FDA it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Courcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri 3 losames over device complies with other requirements of the Act that i DA has made a acternations administered by other Federal agencies. You must of any it cach statutes and regaraments, including, but not limited to: registration and listing (21 comply with an the Act stequirements, now and acturing practice requirements as set Crk Fart 807), labeling (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manteang your ntial equivalence of your device to a legally premarked notification. "The PDF Intering sification 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 If you desire specific advice tor your don't a long of ease note the regulation entitled, comact the Office of Compuner as (21 transmit (21CFR Part 807.97). You may obtain "Misoranding by reference to premainter to promainter the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number [phone] or Manufacturers, International and Octess http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Indication for Use Form

510(k) Number (if known):

K 050950

DEVICE NAME: Crystal , Record & Optima

INDICATION FOR USE:

The Crystal , Record & Optima are generally intended for dermatological use. The I no or your , resear a sedicated for removal of hair by using selective light energy.

(Please do not write below this line - continue on another page if needed)

( Concurrence of CDRH, Office of Device Evaluation (ODE) )

Muriam C. Provost

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

Prescription Use ✗
(Per 21 CFR 801.109)

510(k) Number
OR

K050950
Over-the-Counter-Use **__**