MM-RUBY

K970475 · American Lasers, Inc. · GEX · Sep 29, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970475
• Device Name: MM-RUBY
• Applicant: American Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Q-SWITCHED MODE: FOR LIGHTENING OF TATTOOS (BLACK, YELLOW, AND BLUE INKS). LONG-PULSE MODE: FOR TREATMENT OF BENIGN SUPERFICIAL PIGMENTED SKIN LESIONS --LENTIGINES --CAFE-AU-LAIT --EPHELIDES

Device Story

MM-RUBY is a laser system operating in two modes: Q-switched and long-pulse. Q-switched mode targets tattoo inks (black, yellow, blue) for lightening; long-pulse mode treats benign superficial pigmented skin lesions including lentigines, cafe-au-lait, and ephelides. Device is intended for use by physicians in clinical settings. Laser energy is delivered to the skin to achieve therapeutic effects on pigments. Output is controlled by the operator to match lesion type and patient needs. Benefits include non-invasive removal or reduction of tattoos and pigmented lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ruby laser system; dual-mode operation (Q-switched and long-pulse). Class II device. Operates under 21 CFR 800-895. No specific materials or software algorithms described.

Indications for Use

Indicated for lightening of tattoos (black, yellow, blue inks) using Q-switched mode and treatment of benign superficial pigmented skin lesions (lentigines, cafe-au-lait, ephelides) using long-pulse mode.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

David K. Quon, M.D.
• President
American Lasers, Inc.
300 East Main Street
Alhambra, California 91801

SEP 29 1997

Re: K970475
Trade Name: MM-RUBY
Regulatory Class: II
Product Code: GEX
Dated: August 30, 1997
Received: September 4, 1997

Dear Dr. Quon:

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 requirements, 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.

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Page 2 - David K. Quon, M.D.

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,


Enclosure

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Page 1 of 1

510(k) Number (if known): K970475

Device Name: MM-RUBY

Indications For Use:

Q-SWITCHED MODE:
FOR LIGHTENING OF TATTOOS (BLACK, YELLOW, AND BLUE INKS).

LONG-PULSE MODE:
FOR TREATMENT OF BENIGN SUPERFICIAL PIGMENTED SKIN LESIONS
--LENTIGINES
--CAFE-AU-LAIT
--EPHELIDES
*New 109*

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR Over-The-Counter Use
(Optional Format 1-2-96)