(70 days)
Not Found
Not Found
No
The document describes a pulsed light device with standard components and no mention of AI/ML in the intended use, device description, or specific sections for AI/ML details.
Yes.
The device is intended for the treatment of various medical conditions such as vascular and benign pigmented lesions, warts, scars, striae, facial and leg veins, and acne, which are all therapeutic interventions.
No
The device description and intended use indicate that this product is for therapeutic treatments (e.g., hair removal, treatment of lesions, acne) using pulsed light technology, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components: a Principal Unit, a Handpiece, and a Lamp & Filter group, which are essential for the device's function of emitting pulsed light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions on the patient's skin (hair removal, treatment of lesions, acne). IVDs are used to diagnose or monitor conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The device emits light applied to the patient's skin. This is a therapeutic action, not a diagnostic one.
- Anatomical Site: The device is applied to the skin, which is the site of treatment, not the source of a sample for in vitro analysis.
In summary, this device is a therapeutic device that uses light energy to treat various skin conditions. It does not perform any in vitro analysis of biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
This product is intended for dermatological use by physicians and healthcare professionals for the following:
- Removal of unwanted hair in all skin types (from 570 to 1200nm filter) .
- Treatment of vascular and benign pigmented lesions, cutaneous lesions including . warts, scars, strine and facial and leg veins (from 550 to 1200nm filter).
- Treatment of Acne (from 390 to 1200nm filter) .
Product codes
GEX
Device Description
The device is designed and manufactured to emit a high intensity pulsed light applied to the patient's skin. The light is emitted by a quick discharge of some capacitors on a xenon flash lamp with a high energy. The lamp delivers a wavelength in the band of 390-1200nm. The three principal parts of the system include:
- The Principal Unit, that contain all circuitry to control the device as the ♥ capacitor charge system, the microcontroller and all the electronic parts; the
- The Handpiece, that contain part of circuitry to control the Lamp & Filter キ group;
- The Lamp & Filter group, a removable box that contain Xenon Flash Lamp . and Filter mounted on to the handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dermatological use by physicians and healthcare professionals
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)
Not Found
Reference Device(s)
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
EPI-C PLUS
CONFIDENTIAL
MAY - 1 2007
SECTION 4: EXECUTIVE SUMMARY
Device Description
The device is designed and manufactured to emit a high intensity pulsed light applied to the patient's skin. The light is emitted by a quick discharge of capacitors on a xenon flash lamp with a high energy. The lamp delivers a wavelength in the band of 390-1200nm.
The three principal parts of this system are:
- The Principal Unit which contain all circuitry to control the device. This unit 】. is composed of:
- . Power Supply section which allows the necessary power supply to the system (power supply socket, main switch, power supply transformer, and the Ac/Dc the power supply converter, for PC board).
- Control section is composed of control board PC board and human . interface system (TFT display )
- Power section allows generating and storing the energy used to generate . the output light. It is composed of power board and power capacitors.
-
- The Handpiece contains circuitry to control the Lamp & Filter group. It is connectod with the principal unit with a removable cable
-
- The Lamp & Filter group is a removable box that contains Xenon Flash Lamp and Filter mounted on to the handpiece.
Intended Use
This product is intended for dermatological use by physicians and healthcare professionals for the following:
- Removal of unwanted hair in all skin types (from 570 to 1200nm filters) �
- Treatment of vascular and benign pigmented lesions, cutaneous lesions including � warts, scars, striae and facial and leg veins (from 550 to 1200mm filter)
- Treatment of Acne (from 390 to 1200nm filter) .
1
EPI-C PLUS
Device Description
The device is designed and manufactured to emit a high intensity pulsed light applied to the patient's skin. The light is emitted by a quick discharge of some capacitors on a xenon flash lamp with a high energy. The lamp delivers a wavelength in the band of 390-1200nm. The three principal parts of the system include:
- The Principal Unit, that contain all circuitry to control the device as the ♥ capacitor charge system, the microcontroller and all the electronic parts; the
- The Handpiece, that contain part of circuitry to control the Lamp & Filter キ group;
- The Lamp & Filter group, a removable box that contain Xenon Flash Lamp . and Filter mounted on to the handpiece.
Intended Use
This product is intended for dermatological use by physicians and healthcare professionals for the following:
- Removal of unwanted hair in all skin types (from 570 to 1200nm filter) .
- Treatment of vascular and benign pigmented lesions, cutaneous lesions including . warts, scars, strine and facial and leg veins (from 550 to 1200nm filter).
- Treatment of Acne (from 390 to 1200nm filter) .
Comparison to Predicate Devices
The intended use and the technological characteristics of the Espansione Marketing EPI-C PLUS and its predicate devices are very similar as explained in section 6 of this submission. Espansione Marketing EPI-C PLUS is substantially equivalent to its predicate device cited above, and raises no new safety and/or efficacy issues.
Page 5 of 30
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tails, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Espansione Marketing SPA % Isenet Guido Bonapace Via Emilia, 418 40068 – San Lazzaro di Savena Bologna, Italy
MAY - 1 2007
Re: K070494 Trade/Device Name: EPI-C PLUS 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: February 15, 2007 Received: February 20, 2007
Dear Guido Bonapace:
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, Drug, 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.
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 requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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
3
Page 2 – Guido Bonapace
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 1000-1050.
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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number : K070494
Device Name: EPI-C PLUS
Indications for Use:
This product is intended for dermatological use by physicians and healthcare professionals for the following:
- Removal of unwanted hair in all skin types (from 570- to 1200mm filter) .
- Treatment of vascular and benign pigmented lesions, cutaneous lessons including . warts, scars, striae and facial and leg veins (from 550 to 1200mm filter).
- Treatment of Acne (from 390 to 1200nm filter) .
AND/OR Over-the-Counter Use Prescription Use _ X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
** CERTIFICATION IS TO BE ON COMPANY LETTERHEAD, SIGNED AND DATED BY THE RESPONSIBLE INDIVIDUAL ** ]
(Division Sign-Off)
Division of General, Restorative,
Division of General, Restorative,
Espansione, Mark and Neurological Devices
EPI-C PLUS
510(k) Number LG74949
Page x
CONFIDENTIAL