SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER

K971879 · Continuum Biomedical, Inc. · GEX · Aug 14, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971879
• Device Name: SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER
• Applicant: Continuum Biomedical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For general dermatology (soft tissue ablation) and skin resurfacing in the treatment of wrinkles

Device Story

Scanning Device Accessory for CB Erbium/2.94 Er:YAG laser; microprocessor-controlled; generates defined, repeatable patterns in automated sequence; increases treatment speed; facilitates uniform tissue ablation. Used in dermatology/skin resurfacing; operated by physician. Enhances clinical procedure efficiency while maintaining performance characteristics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-controlled scanning accessory for Er:YAG laser system. Designed for automated beam delivery patterns to facilitate uniform tissue ablation.

Indications for Use

Indicated for general dermatology (soft tissue ablation) and skin resurfacing in the treatment of wrinkles.

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

• SoftScanTM Scanning Device, Sahar Technologies, Inc. (K964684)

Submission Summary (Full Text)

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K971879

| | 510(k) Summary | | AUG 1 4 1997 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|
| Submitter: | Continuum Biomedical<br>A Medical Division of Continuum Electro-Optics, Inc.<br>6533 Sierra Lane<br>Dublin, CA 94568 | | |
| Contact: | Robert S. Anderson, Ph.D.<br>President | | |
| Date Summary Prepared: | May 20, 1997 | | |
| Device Trade Name: | Scanning Device Accessory for the CB Erbium / 2.94TM Er:YAG Laser | | |
| Common Name: | Medical laser system | | |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 | | |
| Equivalent Device: | SoftScanTM Scanning Device, Sahar Technologies, Inc. (K964684) | | |
| Device Description: | The Scanning Device Accessory is a microprocessor controlled device<br>that generates precisely defined repeatable patterns in an automated<br>sequence to increase treatment speed and facilitate uniform ablation of<br>tissue. | | |
| Intended Use: | For general dermatology (soft tissue ablation) and skin resurfacing in<br>the treatment of wrinkles | | |
| Comparison: | The Scanning Device Accessory for the CB Erbium / 2.94 TM Er:YAG<br>Laser is manufactured for Continuum Biomedical by Sahar<br>Technologies, Inc. (K964684, SE 02/14/97). | | |
| Nonclinical Performance Data: | none | | |
| Clinical Performance Data: | none | | |
| Conclusion: | The Scanning Device Accessory for the CB Erbium / 2.94 TM Er:YAG<br>Laser enhances the clinical application procedure while maintaining the<br>performance characteristics. | | |
| Additional Information: | None requested at this time. | | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three wavy lines representing the body and head.

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

AUG 1 4 1997

Re: K971879

Trade Name: Scanning Device Accessory for use with the CB Erbium/2.94TM Er: YAG Laser Regulatory Class: II Product Code: GEX Dated: May 20, 1997 Received: May 21, 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 (OS) 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

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## Page 2 - Ms. Laurie A. Ridener

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.

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,

toscellef

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

971879

| 510(k) Number (if known): | pending |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | --CB Erbium / 2.94™ Er:YAG Laser |
| Indications for Use: | Scanning Device Accessory for use with the CB Erbium / 2.94™<br>Er:YAG Laser for general dermatology (soft tissue ablation) and<br>skin resurfacing in the treatment of wrinkles. |

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K971879 |
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-the-Counter Use |

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