(87 days)
Not Found
Not Found
No
The device description mentions a microprocessor-controlled system but does not include any terms or descriptions related to AI, ML, image processing, or data-driven algorithms. The performance study section also indicates no data was required or submitted, which is less common for devices heavily reliant on complex AI/ML algorithms.
No
The device is intended for cosmetic procedures like hair removal and treatment of benign lesions, not for the treatment or diagnosis of diseases or medical conditions.
No
The device is described for "Removal of unwanted hair" and "Treatment of vascular and benign pigmented lesions," which are therapeutic or cosmetic applications, not diagnostic.
No
The device description explicitly lists hardware components such as a microprocessor controlled system, Xenon lamp, capacitor charge system, electronic control system, handpiece with lamp box, and control panel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dermatological procedures performed by physicians, specifically for hair removal and treatment of skin lesions. This involves direct interaction with the patient's body.
- Device Description: The device is an Intense Pulsed Light System that uses a Xenon lamp to deliver light to the skin. This is a physical treatment method applied externally.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
Therefore, the Flash 1 Intense Pulsed Light System is a therapeutic device used for dermatological treatments, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flash 1 is intended for dematological use by a physician for treatment of vascular and benign pigmented lesions and removal of unwanted hair in all skin types.
This product is intended for dermatological use by physicians for the following:
- Removal of unwanted hair in all skin types
- Treatment of vascular and benign pigmented lesions
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Flash 1 Intense Pulsed Light System is a microprocessor controlled system, which uses a Xenon lamp that delivers a wavelength of 590 nanometers. The four principal parts of the system include the capacitor charge system, the electronic control system, the handpiece with lamp box and the control panel.
Mentions image processing
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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
dermatological use by physicians
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). A data base search has been performed to evaluate any adverse effects of the device that is currently marketed. No data submitted for section 807.92 6[(b)(1)(2)(3c)].
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.
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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.
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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
OCT 31 2002
510(k) SUMMARY
KO22583
- Applicant: emed, Inc. 191 West Wilbur Road, Suite 103, Thousand Oaks, Address: CA 91350 2. Contact Persons: Cornelia Damsky Tel: (203) 323-7535 Kenneth Karasiuk Tel: (805)-446-2200 Ext 14 July 29, 2002 3. Preparation Date: 4. Device Submitted: Flash 1 and accessories 5. Proprietary Name: Flash 1 6. Common Name: Intense Pulsed Light System 7. Classification Name: Laser surgical instrument for use in General and Plastic Surgery and in Dermatology. Product Code GEX, Panel 79 8. Predicate Device: The Flash 1 is substantially equivalent to the following currently marketed devices: Palomar's EsteLux, Medical Bio Care's ProLite Pulsed Light Systems, Radiancy's Spa Touch and ESC Medical System's IPL Quantum SR. 9. Device Description The Flash 1 Intense Pulsed Light System is a microprocessor controlled system, which uses a Xenon lamp that delivers a wavelength of 590 nanometers. The four principal parts of the system include the capacitor charge system, the electronic control system, the handpiece with lamp box and the control panel. 10. Intended Use: The Flash 1 is intended for dematological use by a physician for treatment of vascular and benign pigmented lesions and removal of unwanted hair in all skin types. 11. Performance Data: No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). A data base search has been performed to evaluate any adverse effects of the device that is currently marketed. No data submitted for section 807.92
6[(b)(1)(2)(3c)].
1
SUMMARY:
Beginning with the year, 1966, to the present, a database search was completed for adverse safety and effectiveness reported with use of a pulsed light system for hair removal, treatment of vascular and benign pigmented lesions.. The results of the database search are located in Appendix G.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
emed. Inc.
Ms. Cornelia Damsky . 191 West Wilbur Road, Suite 103 Thousand Oaks, California 91360
OCT 31 2002
Re: K022583
Trade/Device Name: Flash 1 Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 29, 2002 Received: August 5, 2002
Dear Ms. Damsky:
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 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.
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Page 2 - Ms. Cornelia Damsky
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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.
Muriam C. Provost
- for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Flash 1
This product is intended for dermatological use by physicians for the following:
- Removal of unwanted hair in all skin types ■
:
. '
- Treatment of vascular and benign pigmented lesions 트
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022583