(76 days)
SofTouch Scanning Device, Skinscan, SureScan
No
The description mentions a "microprocessor-controlled accessory" that guides laser energy, but there is no mention of AI, ML, image processing, or any learning or adaptive capabilities. The justification for no performance studies is based on similarity to predicate devices, not on validation of an AI/ML algorithm.
No.
The device is described as an "accessory to surgical lasers" and "guides the laser energy over the skin during removal of soft tissue," suggesting it primarily assists in the delivery of treatment rather than directly providing a therapeutic effect itself.
No
The device is described as an accessory to surgical lasers for the ablation and vaporization of soft tissue, guiding laser energy. There is no mention of it being used to identify or diagnose medical conditions.
No
The device description explicitly states it is a "microprocessor-controlled accessory" and "guides the laser energy over the skin," indicating it is a hardware device with embedded software, not a standalone software-only device.
Based on the provided information, the JENASCAN is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an accessory to surgical lasers for the ablation and vaporization of soft tissue. This is a direct surgical procedure performed on a patient, not a test performed on a sample taken from the body.
- Device Description: The description reinforces its role in guiding laser energy over the skin for soft tissue removal, again indicating a surgical application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The JENASCAN's function is to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
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 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.
Product codes
GEX
Device Description
The Jenoptik JENASCAN is a microprocessor-controlled accessory for lasers used in dermatology and plastic surgery. The JENASCAN 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
SofTouch Scanning Device (Sahar Technologies), Skinscan (Candela Corporation), SureScan (Clinicon Corporation)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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 | |
| +49 3641 65 3582 | |
| +49 3641 65 3667 (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 | |
| 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 |
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| 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). |
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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.
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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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