LASEAWAY ALEXANDRITE LASER SYSTEM

K982316 · Silver Creek, Inc. · GEX · Dec 16, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982316
• Device Name: LASEAWAY ALEXANDRITE LASER SYSTEM
• Applicant: Silver Creek, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LaseAway Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The LaseAway Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.

Device Story

LaseAway Alexandrite Laser System emits invisible 755 nm laser beam for hair removal; includes visible aiming beam for guidance. Operates at pulse width of nominally 1 msec at 1 Hz, up to 3 Hz; also provides modulated single pulse of 6 x 1 msec pulses at 1.3 Hz. Used in clinical settings by trained physicians. Physician directs laser energy at target hair follicles to achieve cosmetic removal. Benefits include non-invasive hair reduction for adult patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and compliance with safety standards for laser products.

Technological Characteristics

Alexandrite laser source; 755 nm wavelength; visible aiming beam. Pulse width 1 msec; repetition rates up to 3 Hz; modulated pulse mode (6 x 1 msec pulses). Class IV laser product. Safety design per BS EN 60825-1 and BS EN 6061-2-22. Labeling per 21 CFR subchapter J.

Indications for Use

Indicated for cosmetic removal of unwanted hair in adults 18 years or older. Intended for use by qualified physicians trained in system operation.

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

• Sharplan Epitouch Alexandrite Laser System (K973354)
• Sharplan Epitouch Alexandrite Laser System (K971874)
• Medlite/755 Alexandrite Laser System (K961006)
• Candella Q-Switched Alexandrite Lasers (K955662)
• Candella Q-Switched Alexandrite Lasers (K940173)
• Candella Q-Switched Alexandrite Lasers (K944090)

Submission Summary (Full Text)

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K9823/6

Image /page/0/Picture/1 description: The image shows the logo for Silver Creek Surgical. The logo is in black and white and features the words "Silver Creek" in a stylized font, with the word "Surgical" underneath in a smaller font. To the right of the logo is a starburst design. Above the logo, the date "DEC 16 1998" is printed in a simple font.

1310 Rockbridge Road • Suite E • Stone Mountain, GA 30087 770-931-1090 • Fax [phone] E-Mail: [e-mail] Website: http://www.silvercreeksurgical.com

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Date: | July 1, 1998 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared By: | Lorna K. Linville |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48, Class II |
| Proprietary Name: | LaseAway Alexandrite Laser System |
| Indications: | The LaseAway Alexandrite Laser is intended for the cosmetic<br>removal of unwanted hair on adults (18 years or older). The<br>LaseAway Alexandrite Laser System is intended for use only by<br>qualified physicians trained in the safe operation of the system. |
| Description: | The LaseAway Alexandrite Laser System is a medical device<br>which is capable of emitting an invisible treatment laser beam at a<br>wavelength of 755 nm under the guidance of a visible aiming<br>beam. In addition to the standard pulse width of nominally 1 Msec<br>at 1Hz, the LaseAway Alexandrite Laser System will operate up<br>to 3 Hz. Additionally, a single pulse is modulated to provide 6 x 1<br>Msec pulses at 1.3 Hz. |
| Safety Features: | The safety features of the device have been designed in<br>accordance with relevant standards such as BS EN 60825-1<br>(Safety of Laser Product) and BS EN 6061-2-22 (Medical<br>Electrical Equipment Safety). The labeling complies with 21 CFR<br>subchapter J for a Class IV laser product. |
| Predicate Devices: | The LaseAway Alexandrite Laser System is substantially<br>equivalent to numerous devices that are currently commercially<br>available. These devices include the Sharplan Epitouch<br>Alexandrite Laser System (K973354 and K971874), Medlite/755<br>Alexandrite Laser System (K961006), and Candella Q-Switched<br>Alexandrite Lasers (K955662, K940173 and K944090). |
| Conclusion: | The LaseAway Alexandrite Laser System is safe and effective<br>for the intended purpose of removal of unwanted body hair on<br>adults 18 years of age or older. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of an eagle or bird-like figure with three stylized lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 1998

Ms. Lorna K. Linville Quality/Regulatory Specialist Silver Creek Surgical 1310 Rockbridge Road, Suite E Stone Mountain, Georgia 30087

Re: K982316

Trade Name: LaseAway Alexandrite Laser System Regulatory Class: II Product Code: GEX Dated: October 1, 1998 Received: October 5, 1998

Dear Ms. Linville:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Lorna K. Linville

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

fr
pollpa
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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510(k) Number (if Known): _K982 316

LaseAway Alexandrite Laser System Device Name:

Indications For Use:

The LaseAway Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The LaseAway Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.

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

Concurrence of ODRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | 4982316 |

| Prescription Use | X | OR | Over-The-Counter Use |
|------------------|---|----|----------------------|
|------------------|---|----|----------------------|

OR

Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)