MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER

K970808 · Continuum Biomedical, Inc. · GEX · Sep 5, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970808
• Device Name: MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER
• Applicant: Continuum Biomedical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For incision, excision, ablation, vaporization in soft tissue for general dermatology. 1064nm wavelength: Dark ink (blue, black) tattoo removal Nevus of Ota. 532nm wavelength: Light ink (red) tattoo removal, vascular lesions, epidermal pigmented lesions.

Device Story

Medlite IV™ is a Q-switched Nd:YAG laser system for dermatological procedures. System components include power supply, water cooling system, and optical bench (YAG rod, flashlamp, mirrors, frequency doubler, articulated arm). Operation involves flashlamp excitation via high-voltage electrical pulse, causing YAG rod to emit 1064nm laser light. Q-switch acts as high-speed shutter for pulse control (1, 2, 5, 10 Hz or single shot). Frequency doubler enables 532nm wavelength output. Used by clinicians in dermatological settings for tissue ablation and lesion/tattoo removal. Output is delivered via articulated arm to target tissue; clinical effect is achieved through light-tissue interaction. Benefits include precise tissue removal and pigment/vascular lesion treatment.

Clinical Evidence

No clinical data presented.

Technological Characteristics

Q-switched Nd:YAG laser system; wavelengths 1064nm and 532nm (via frequency doubler); pulse rates 1, 2, 5, 10 Hz or single shot; articulated arm delivery; water-cooled; electrical power supply.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, or vaporization in general dermatology, including removal of dark ink (blue/black) tattoos, light ink (red) tattoos, Nevus of Ota, vascular lesions, and epidermal pigmented lesions.

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

• Polytec PI LaseAway Nd:YAG Laser (K942622)

Submission Summary (Full Text)

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K970808 / S2 Additional Information
Medlite IV™ Q-Switched Nd:YAG Laser System
Continuum Biomedical
August 1, 1997
SEP -5 1997
K970808

# 510(k) Summary

| Submitter: | Continuum Biomedical
A Medical Division of Continuum Electro-Optics, Inc.
6533 Sierra Lane
Dublin, CA 94568
phone: [phone]
fax: [phone] |
| --- | --- |
| Contact: | Laurie A. Ridener
Regulatory Affairs Officer |
| Date Summary Prepared: | August 1, 1997 |
| Device Trade Name: | Medlite IV™ Q-Switched Nd:YAG Laser System |
| Common Name: | Medical laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CRF 878.48 |
| Equivalent Device: | Polytec PI LaseAway Nd:YAG Laser (Lambda Photometrics, Ltd.)
(K942622) |
| Device Description: | Medlite IV™ consists of three main components: the power supply used to provide the proper voltage and current to the laser system, the water cooling system used to remove heat from the power supply and the optical bench consisting of the YAG rod, flashlamp, various mirrors, frequency doubler crystal and articulated arm. |

The lasing action of the Medlite IV™ occurs when first the flashlamp is excited by a high voltage electrical pulse from the power supply. The excited flashlamp then emits an intense broad-spectrum light. The YAG rod absorbs most of this light and then releases the energy as laser light at 1064nm.

The Q-Switch acts as an extremely high speed shutter and can be set to release the light at pulse rates of 1, 2, 5, and 10 pulses per second or single shot. The frequency doubler can be enabled to change the 1064nm (infrared) light to a second wavelength at 532nm (green).

PROPRIETARY DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continuum Biomedical, A Medical Division of Continuum Electro-Optics, Inc.
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K970808 / S2 Additional Information
Medlite IV™ Q-Switched Nd:YAG Laser System
Continuum Biomedical
August 1, 1997

510(k) Summary (cont'd)

Intended Use: For incision, excision, ablation, vaporization of soft tissue for general
dermatology, as well as at the 1064nm wavelength, dark ink
(blue/black) tattoo removal and Nevus of Ota and at the 532nm
wavelength, light ink (red) tattoo removal, vascular and pigmented
lesions.

Comparison: Medlite IV™ Q-Switched Nd:YAG Laser and the Polytec PI
LaseAway Nd:YAG Laser (Lambda Photometrics, Ltd.) are equivalent
in operating parameters, physical characteristics and intended uses.

Nonclinical Performance Data: None presented at this time.

Clinical Performance Data: None presented at this time.

PROPRIETARY DATA: This document and information contained herein may not be reproduced, used or disclosed
without written permission of Continuum Biomedical, A Medical Division of Continuum Electro-Optics, Inc.

07

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Laurie A. Ridener
Regulatory Affairs Officer
Continuum Biomedical, Inc.
6533 Sierra Lane
Dublin, California 94568

SEP - 5 1997

Re: K970808
Trade Name: Medlite IV™ Q-Switched Nd:YAG Laser System
Regulatory Class: II
Product Code: GEX
Dated: June 13, 1997
Received: June 16, 1997

Dear Ms. Ridener:

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 - Ms. Laurie A. Ridener

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,


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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Page 1 of 1

510(k) Number (if known): K970808

Device Name: Medlite IV™ Q-Switched Nd:YAG Laser System

Indication for Use: For incision, excision, ablation, vaporization in soft tissue for general dermatology

## Specific Indications:

1064nm wavelength: Dark ink (blue, black) tattoo removal
Nevus of Ota

532nm wavelength: Light ink (red) tattoo removal
Vascular lesions
Epidermal pigmented lesions

(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 Devices
510(k) Number K970808

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-the-Counter Use ☐

(Optional Format 1-2-96)