(247 days)
Not Found
No
The description mentions a "microprocessor-controlled" device with "pre-set and manual delivery parameters," but there is no mention of AI, ML, or any learning or adaptive capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found."
Yes.
The device is designed for permanent hair reduction and treatment of various skin conditions, which are therapeutic interventions.
No
The device is designed for permanent hair reduction and treatment of skin conditions, not for diagnosing medical conditions.
No
The device description explicitly states it is a "microprocessor-controlled nonablative xenon flash lamp-based medical device" and lists hardware components such as a "photothermolysis handle with treatment head," "keys for main switch," "foot switch," and "electric power cable." This indicates it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne. These are all treatments applied directly to the patient's body.
- Device Description: The device is described as a light-based medical device that delivers pulsed light to the treated area. This is a physical treatment method, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Depilite EL-8b Series DERMO FLASH™ Systems are microprocessorcontrolled nonablative light-based medical devices designed for permanent hair reduction, and the treatment of vascular and benign pigmented lesions and inflammatory acne, on skin types I-IV.
The Depilite EL-8b DERMO FLASH™ Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
The Depilite EL-8b DERMO FLASH™ Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction.
The Depilite EL-8b DERMO FLASH™ Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.
The Depilite EL-8b DERMO FLASH™ Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Depilite EL-8b Series DERMO FLASH™ devices are microprocessor-controlled nonablative light-based medical devices which use pulsed xenon lamps to deliver a selectable range of polychromatic light outside the range of harmful ultraviolet wavelengths leaving only the visual and infrared light to be presented for photo thermolysis epilation and skin treatments. Pre-set and manual delivery parameters - such as the appropriate wavelength, energy, pulse rate and exposure time - and other system features are modulated from the display and control panel on the main unit. The corresponding fluence is delivered through an air-cooled double lamp hand piece without making contact with the treated area (Non Contact Pulsed Light or NCPL™). The complete system consists of the Depilite EL-8b DERMO FLASH™ machine, a photothermolysis handle with treatment head, keys for main switch, a foot switch, electric power cable, protective goggles, and instruction manual,
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)
Not Found
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.
K043319, K023081, K022583, K991935
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
510(k) Number K052371
MAY - 4 2006
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
510(k) Summary Statement for MED-OP Aesthetic Technologies, Ltd. Depilite EL-8b Series DERMO FLASH™ Systems
Regulatory Authority:
Safe Medical Devices Act of 1990, Title 21 C.F.R. Section 807.92
Submitter's Name:
Hair International Systems USA, Inc. 11526 Sorrento Valley Road, Suite IB San Diego, California 92121 Tel: (858) 755-5758 Fax: (858) 755-5574
Contact Person:
Amnon Zakay, President and CEO
Name of Devices:
Depilite EL-8b Series DERMO FLASH™ Systems (and Delivery Accessories):
- DERMO FLASH™ Model A .
- . DERMO FLASH™ Model SX-513 A
- . DERMO FLASH™ Model SX-513 C
- . DERMO FLASH™ Model C
Common Names:
Dermatology Flash Lamp Systems
Section II - Page 1 of 3
1
2371
510(K) PREMARKET NOTIFICATION Depilite EL-8b Series DERMO FLASH™ Systems MED-OP Aesthetic Technologies, Ltd. March 20, 2006
Classification:
Laser surgical instrument for use in general and plastic surgery and in dermatology. Title 21 C.F.R. Section 878.4810
Medical Specialty - General & Plastic Surgery
Device Class II - Special Controls
Product Code - GEX
Panel - 79
Equivalent Devices:
Light-Emitting Source: Flash Lamp Intense Pulsed Light (IPL) Technology:
- . Clareon™ Pulsed Light System Solarus™ Pulsed Light System Novalis Medical, LLC K043319, Dec. 17, 2004
- . ProLite / Plasmalite MPX Pulsed Light System Medical Bio Care Nordic AB K023081, Dec. 16, 2002
- Flash 1 . emed, Inc. K022583, Oct. 31, 2002
- . EpiLight® PhotoDerm® HR ESC Medical Systems, Ltd. K991935, January 27, 2000
Section II - Page 2 of 3
2
f 2371
510(K) PREMARKET NOTIFICATION Depilite EL-8b Series DERMO FLASH™ Systems MED-OP Aesthetic Technologies, Ltd. March 20, 2006
Description of the DERMO FLASH™ Series Devices:
The Depilite EL-8b Series DERMO FLASH™ devices are microprocessorcontrolled nonablative light-based medical devices which use pulsed xenon lamps to deliver a selectable range of polychromatic light outside the range of harmful ultraviolet wavelengths leaving only the visual and infrared light to be presented for photo thermolysis epilation and skin treatments. Pre-set and manual delivery parameters - such as the appropriate wavelength, energy, pulse rate and exposure time - and other system features are modulated from the display and control panel on the main unit. The corresponding fluence is delivered through an air-cooled double lamp hand piece without making contact with the treated area (Non Contact Pulsed Light or NCPL™). The complete system consists of the Depilite EL-8b DERMO FLASH™ machine, a photothermolysis handle with treatment head, keys for main switch, a foot switch, electric power cable, protective goggles, and instruction manual,
The Depilite EL-8b Series DERMO FLASH™ devices are in compliance with mandatory special controls as required by 21 C.F.R. Part 1040 – Performance Standards for Light-Emitting Products.
Indications for Use:
The Depilite EL-8b Series DERMO FLASH™ Systems are microprocessorcontrolled nonablative light-based medical devices designed for permanent hair reduction, and the treatment of vascular and benign pigmented lesions and inflammatory acne, on skin types I-IV.
Substantial Equivalency:
The differences in specifications of the Depilite EL-8b Series DERMO FLASH™ devices and the predicate device(s) do not result in different performances or raise new questions of safety or efficacy.
Conclusion:
The Depilite EL-8b Series DERMO FLASH™ Systems are substantially equivalent to other legally-marketed flash light-based medical devices in U.S. commercial distribution for the same dermatological applications.
Section II - Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2006
Hair International Systems USA, Inc. c/o Horton, Whiteley & Cooper Mr. Craig A. Mitchell 4590 Macarther Boulevard - Suite 500 15770 Laguna Canyon Road Newport Beach, California 92692
Re: K052371 Trade/Device Name: Depilite EL-8B Series DERMO FLASH™ System DERMO FLASH" Model A M DERMO FLASH' Model SX-513 A DERMO FLASH™ Model SX-513 C DERMO FLASH™ Model C Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 21, 2006 Received: April 25, 2006
Dear Mr. Mitchell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, J rug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Craig A. Mitchell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other maution wour not not incant or any Federal statutes and regulations administered by other Federal agencies. You must CED Dec 20T all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1000. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note (21 cr regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain other general information on your responsibilities under the Act from the Division of Stoull Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain/html
Sincerely yours,
Hukukemena
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number (if known): | 510(k) Number K052371 |
|---|---|
| Device Name: | Depilite EL-8b Series DERMO FLASH TM Systems |
| Indications For Use: | The Depilite EL-8b DERMO FLASH TM Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. |
| The Depilite EL-8b DERMO FLASH TM Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. | |
| The Depilite EL-8b DERMO FLASH TM Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne. |
Prescription Use __ X (Part 21 CFR 801 Subpart D)
. . . . . . . . . .
..
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Humphrey
(Division Sign-Off) (Division of General, Restorative,
Division of General, Restorative, Page 1 of _1 and Neurological Devices
- Number K052371
- Caller Baker Sa
-
- 1
.
6
Indications for Use
510(k) Number (if known):
510(k) Number K052371
Device Name: Depilite EL-8b DERMO FLASH™ Systems
Indications For Use:
And The France of the comments of
The Depilite EL-8b DERMO FLASH™ Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.
Page 2 of 2
and the same of the status and the season the season