LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE

K991285 · Aesculap-Meditec North America · GEX · Jul 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991285
• Device Name: LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE
• Applicant: Aesculap-Meditec North America
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The laser system Ruby Star (operating in normal use) is intended to remove unwanted body hair. The laser system Ruby Star (operating in Q-Switch mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions. Some examples of pigment lesions are: Lentigines, Cafe-au-lait-blotches, Ephalides, Benign Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi, Congenital naevi, Becker's naevi, Blue naevus, Naevus spilus, and Mongolian spot. The laser system Ruby Star is restricted to sale or use by licensed professionals in the United States

Device Story

RubyStar is a ruby laser system emitting coherent light at 694 nm. Operates in two modes: normal pulse for hair removal and Q-Switched mode for soft tissue cutting, vaporization, or ablation (tattoo removal, pigmented lesions). Used by licensed professionals in clinical settings. Device delivers laser energy to target tissue; provider directs beam to achieve desired surgical or dermatological effect. Benefits include precise tissue interaction for aesthetic and surgical applications.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence established through comparison of specifications and intended use to legally marketed predicate devices.

Technological Characteristics

Ruby laser system; 694 nm wavelength; normal and Q-Switch pulse modes. Class II surgical laser instrument. No specific materials or software architecture details provided.

Indications for Use

Indicated for removal of unwanted body hair (normal mode) and cutting, vaporization, or ablation of soft tissue, including tattoo removal and treatment of benign pigmented lesions (Q-Switch mode) in patients requiring such dermatological or surgical procedures. Restricted to licensed professional use.

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

• MLT R694 (K991285)
• LaseAway Long Pulse and Q-Switched Ruby Laser
• MM-Ruby Laser
• Spectrum RD 1200
• Candela AlexLAZR

Reference Devices

• EpiLaser
• Chromos 694
• Sharplan EpiTouch

Submission Summary (Full Text)

{0}------------------------------------------------

991285

JUL 1 2 1999

## 510(k) SUMMARY AESCULAP-MEDITEC GMBH LASER SYSTEM RubyStar WITH NORMAL AND Q-SWITCH MODE

This 510(k) summary of safety and effectiveness for the AESCULAP-MEDITEC GMBH Laser System RubyStar with normal and Q-Switch mode is submitted in accordance with the requirements of SDMA 1990 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.

AESCULAP-MEDITEC GMBH Applicant:

- Prussinastrasse 41 Address: 07739 Jena, Germany
Contact Person: Dr. Dirk Colditz Quality Management Representative

- Phone: [phone] Fax: [phone] [e-mail] e-mail:
Preparation date: March 1999

Laser System RubyStar Device name:

RubyStar (with normal and Q-Switch mode) Common Name:

Classification Name:

Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) Product code: GEX - Laser instrument, surgical, powered Panel: 79

Legally marketed: MLT R694.LaseAway Long Pulse and Q-Switched Ruby Laser, MM-Ruby, Laser; Sectrum RD 1200; Candela AlexLazar

- Description: The laser system RubyStar operates as a normal pulse or as a Q-Switched ruby laser which emits a beam of coherent light at 694 nanometers. In Q-Switched mode the beam has much shorter pulse duration than in the normal pulse mode.
Intended Use: The laser system RubyStar operating in normal mode is intended to remove unwanted body hair. The laser system RubyStar operating in Q-Switch mode is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigment lesions.

{1}------------------------------------------------

The specifications of the RubyStar laser in the Q-Switch mode Comparison to: are the same as or very similar to those of legally marketed lasers such as the MLT R694(Q-Switch mode), LaseAway Long Pulse and Q-Switched Ruby Laser, the MM-Ruby Laser; the Spectrum RD 1200, and the Candela AlexLAZR. The specifications of the RubyStar operating in normal mode are the same as or very similar to those of legally marketed lasers such as the MLT R694, EpiLaser, Chromos 694, and Sharplan EpiTouch.

- Performance data: None. The specifications and intended uses of the laser system RubyStar operating in Q-Switch or normal mode are the same or very similar to those of claimed predicate devices. Because of this , performance data were not required.
- When operating in Q-Switch or normal mode the RubyStar is CONCLUSION: substantially equivalent to legally marketed devices, e.g. ruby and alexandrite lasers, operating in both Q-Switch or normal mode.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1.2 1999

Mr. William Kelley Aesculap-Meditec North America 2525 McGaw Avenue Irvine, California 92623-9791

Re: K991285

> Trade Name: Laser System Ruby Star (with normal and Q-Switch mode) Regulatory Class: II Product Code: GEX Dated: March 31, 1999 Received: April 15, 1999

Dear Mr. Kelley:

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 Quality 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.

{3}------------------------------------------------

## Page 2 - Mr. William Kelley

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 vour 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,

- 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

{4}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(K) Number (if known): _ GS | 2 8 5

Device Name: Laser System Ruby Star (with normal and O-Switch mode)

Indications For Use Statement:

The laser system Ruby Star (operating in normal use) is intended to remove unwanted body hair.

The laser system Ruby Star (operating in Q-Switch mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.

Some examples of pigment lesions are:

Lentigines, Cafe-au-lait-blotches, Ephalides, Benign Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi, Congenital naevi, Becker's naevi, Blue naevus, Naevus spilus, and Mongolian spot.

The laser system Ruby Star is restricted to sale or use by licensed professionals in the United States

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR
Over-The-Counter Use

(Division Sign-Off) Division of General Restorative Device 510(k) Number