(169 days)
Not Found
No
The summary describes a photothermal device for hair removal and does not mention any AI or ML components or capabilities.
No
The device is intended for the removal of unwanted hair, which is generally considered a cosmetic procedure and not a therapeutic one aimed at treating a disease or condition. While it is an "electro optic medical device," its purpose does not align with typical therapeutic applications.
No
The device is described as being "intended for the removal of unwanted hair" and for "effective photothermal treatment of unwanted hair and its removal," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is an "electro optic medical device," indicating it includes hardware components beyond just software. The performance studies also focus on clinical outcomes related to a physical treatment, not software performance metrics.
Based on the provided information, the PhotoDerm® HR is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for the removal of unwanted hair." This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: It's described as an "electro optic medical device designed for effective photothermal treatment of unwanted hair and its removal." This further confirms its use for direct treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The PhotoDerm® HR does not perform this function.
Therefore, the PhotoDerm® HR is a medical device used for a therapeutic/cosmetic purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PhotoDerm® HR is intended for the removal of unwanted hair.
The PhotoDerm® HR is used for the removal of unwanted hair.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
PhotoDerm® HR is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
ESC Medical Systems has also conducted a multi-center clinical study in which unwanted hair was treated by the PhotoDerm® HR . This study was analyzed and the clearance rates and rate of occurrence of adverse effects of the PhotoDerm® HR were established. This data was compared to published data on the clearance rate and adverse effects of predicate devices. It is ESC's opinion that this comparison demonstrates that the PhotoDerm® HR is as safe and as effective as the predicate devices in the removal of unwanted hair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K963249, K950019, K962109, K963947, K962446
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAY 2 0 1998
K 974536
510(K) SUMMARY- SUMMARY OF SAFETY AND I. EFFECTIVENESS
ESC Medical Systems, Ltd Submitter's name:
Yokneam Industrial Park Submitter's address: PO Box 240 Yokneam 20692 ISRAEL
011-972-4-959-9000 Telephone:
001-972-4-959-9050 Fax:
PhotoDerm® HR Name of device:
Predicate devices:
-
- EpiLight™ Hair Removal System made by ESC Medical Systems of Yokneam, ISRAEL. 510(k) #K963249
-
- LT-100 ND: YAG Laser Hair Removal System made by Thermolase Corporation of San Diego, California. 510(k) #K950019.
-
- SLS Chromos 694 QD Ruby Laser made by Classy Lady by MEHL of Gainesville, Florida. 510(k) #K962109.
-
- Epilaser Normal Mode Ruby Laser made by Spectrum Medical Technologies of Lexington, Massachusetts. 510(k) #K963947.
-
- Sharplan Ruby Laser System made by Sharplan Lasers, Inc of Allendale, New Jersey. 510(k) #K962446.
Description of device:
PhotoDerm® HR is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its removal.
Summary:
Pursuant to section 513(I) of the Safe Medical Devices Act of 1990, ESC Medical Systems has elected to include in this premarket notification a Summary of Safety and Effectiveness upon which we believe a substantial equivalence determination for the PhotoDerm® HR can be based.
Intended use:
The PhotoDerm® HR is intended for the removal of unwanted hair.
ESC Proprietary Information I. 1-1
1
Comparing technical characteristics:
Both a technical comparison and clinical trials were performed by ESC Medical Systems to establish the substantial equivalence to the predicate devices.
ESC Medical Systems has also conducted a multi-center clinical study in which unwanted hair was treated by the PhotoDerm® HR . This study was analyzed and the clearance rates and rate of occurrence of adverse effects of the PhotoDerm® HR were established. This data was compared to published data on the clearance rate and adverse effects of predicate devices. It is ESC's opinion that this comparison demonstrates that the PhotoDerm® HR is as safe and as effective as the predicate devices in the removal of unwanted hair.
No performance standards applicable to the PhotoDerm® HR have been adopted under Section 514 of the Act.
In summary we believe that the analysis and clinical data establish that the PhotoDerm® HR is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Dr. Zvi Ladin ·Vice President Clinical Applications and Regulatory Affairs ESC Medical Systems, Limited Yokneam Industrial Park P.O. Box 240 Yokneam, 20692 Israel
Re : K974536 PhotoDerm HR System Trade Name: Regulatory Class: II Product Code: GEX March 10, 1998 Dated: Received: March 11, 1998
Dear Dr. Ladin:
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 requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Frod and Drug Administration (FDA) will verify such assamptions. 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.
3
Page 2 - Dr. Ladin
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 requlation (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
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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
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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| 510(k) Number (if known): | K974536 |
|---|---|
| Device Name: | PhotoDerm® HR |
Indications For Use:
The PhotoDerm® HR is used for the removal of unwanted hair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)
| (Division Sign-Off) |
|---|
| --------------------- |
| Division of General Restorative Devices | I2994536 |
|---|---|
| 510(k) Number |
| Prescription Use er 21 CFR 801.109) X | OR | Over-The-Counter Use ______ |
|---|---|---|
| --------------------------------------------------------------------------------------- | ---- | ----------------------------- |
(Optional Format 1-2-96)