JENASCAN

K980001 · Jenoptik Laser, Optik, Systeme GmbH · GEX · Mar 19, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980001
• Device Name: JENASCAN
• Applicant: Jenoptik Laser, Optik, Systeme GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JENASCAN is intended for use as an accessory to surgical lasers, e.g., lasers used in dermatology and plastic surgery, for the ablation and vaporization of soft tissue under conditions of use as described in the manuals accompanying the lasers. Please refer to the application, operator's, or user's manual(s) accompanying the laser for professional use instructions and detailed use information concerning the laser.

Device Story

JENASCAN is a microprocessor-controlled accessory for surgical lasers used in dermatology and plastic surgery. Device guides laser energy over skin during soft tissue removal. Operated by clinicians in clinical settings; functionality governed by laser operator's manual. Provides automated scanning patterns to control laser beam delivery; improves precision of tissue ablation/vaporization compared to manual delivery. Benefits patient through controlled, uniform tissue removal.

Clinical Evidence

Bench testing only. No clinical data required as the device is substantially equivalent to existing legally marketed predicate devices.

Technological Characteristics

Microprocessor-controlled laser accessory. Designed for integration with surgical lasers. Operates as a beam-steering/scanning mechanism to guide laser energy. No specific materials or connectivity standards provided.

Indications for Use

Indicated for use as an accessory to surgical lasers in dermatology and plastic surgery for soft tissue ablation and vaporization. Prescription use only.

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

• SofTouch Scanning Device (Sahar Technologies)
• Skinscan (Candela Corporation)
• SureScan (Clinicon Corporation)

Submission Summary (Full Text)

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

g86001

## APPENDIX E

# MAR | 9 1998

### 510(k) SUMMARY

### JENOPTIK L.O.S. JENASCAN

This 510(k) summary of safety and effectiveness for the Jenoptik JENASCAN is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | JENOPTIK, L.O.S., GmbH |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Goschwitzer Str. 25 |
| | D-07739 Jena |
| | Germany |
| | [phone] |
| | [phone] (Fax) |
| US Contact Person: | Mr. William T. Kelley |
| | 23832 Via Monte |
| | Coto De Caza, CA 92679-4001 |
| Telephone: | 714-589-8536 |
| | 714-589-6259 (Fax) |
| Preparation Date: | December 1997 |
| Device Trade Name: | JENASCAN |
| Common Name: | Scanner - an accessory to surgical lasers, especially for use in dermatology and plastic surgery. |
| Classification Name: | None - the scanner has not been classified as a separate device - it is an accessory to surgical lasers, e.g., general and plastic surgery and dermatology (see: 21 CFR 878.4810). Product Code: GEX. |
| Legally marketed<br>predicate devices: | SofTouch Scanning Device (Sahar Technologies and Skinscan (Candela Corporation). |
| Description of Device: | The Jenoptik JENASCAN is a microprocessor-controlled accessory for lasers used in dermatology and plastic surgery. The JENASCAN |

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

| Intended Use: | guides the laser energy over the skin during removal of soft tissue under the conditions of labeling as described in the laser operator's manual. |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The JENASCAN is intended for use as an accessory to lasers used in dermatology and plastic surgery under condition of use as described in the manuals accompanying the laser. |
| | The following is from the Indications for Use Statement for the JENASCAN (APPENDIX B): |
| | The JENASCAN is intended for use as an accessory to surgical lasers, e.g., lasers used in dermatology and plastic surgery, for the ablation and vaporization of soft tissue under conditions of use as described in the manuals accompanying the lasers. |
| | Please refer to the application, operator's, or user's manual(s) accompanying the laser for professional use instructions and detailed use information concerning the laser. |
| Performance Data: | None. The specifications and intended uses of the Jenoptik JENASCAN are the same or very similar to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. |
| | Because of this, performance data were not required. |
| CONCLUSION: | Based on the foregoing and other information in this application, Jenoptik, L.O.S. believes that the JENASCAN is substantially equivalent to legally marketed predicate devices, i.e., SofTouch Scanning Device (Sahar Technologies) and SureScan (Clinicon Corporation). |

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

Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1998

JENOPTIK, L.O.S. GmbH c/o Mr. William T. Kelly 23832 Via Monte 92679-4001 Coto De Caza, California

K980001 Re: Trade Name: JENASČAN Regulatory Class: II Product Code: GEX Dated: January 2, 1998 Received: January 2, 1998

Dear Mr. Kelly:

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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. 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 requlations.

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

Page 2 - Mr. Kelly

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 ene regaracion chercrea/ histranding my Sther 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,

Stephen Rhodes

M. Witten, Ph.D., M.D. irector ivision of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

#### APPENDIX B

#### INDICATIONS FOR USE STATEMENT

5 I 0(K) Number (if known): __ K980001 _______________________________________________________________________________________________________________________________________

Device Name: Jenoptik JENASCAN Scanner

Indications For Use Statement:

ど1/ 秒速アルコミン -- ジェン :- こ

The JENASCAN is intended for use as an accessory to surgical lasers, e.g., lasers used in dermatology and plastic surgery, for the ablation and vaporization of soft tissue under conditions of use as described in the manuals accompanying the lasers.

Please refer to the application, operator's, or user's manual(s) accompanying the laser for professional use instructions and detailed use information concerning the laser.

(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

Statin Rhodes

ision Sibn-Off) ion of General Restorative Devices K98001 510(k) Number

030