(215 days)
No
The device description and performance summary focus on thermal energy delivery and bench testing, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML algorithms.
Yes
The device is indicated for the "treatment of individual acne pimples," which signifies a therapeutic purpose.
No
Explanation: The device is described as a "Cosmetic System" used for "treatment of individual acne pimples" by delivering "thermal energy to the skin." Its function is therapeutic, not diagnostic.
No
The device description explicitly states it is a "compact, handheld device" that delivers "thermal energy" and is "powered by a 9V battery," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ClearFlash AC2100 Function: The ClearFlash AC2100 is a handheld device that applies thermal energy directly to the skin to treat acne. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for the treatment of acne, not for diagnosing or analyzing a condition based on a sample.
The device description and intended use clearly indicate it's a therapeutic device applied externally, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The ClearFlash AC2100 Cosmetic System is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Product codes
OLP
Device Description
The ClearFlash AC2100 is a compact, handheld device that delivers a controlled pulse of thermal energy to the skin for treating dermatological disorders, specifically, mild to moderate inflammatory acne. An acne lesion is treated by applying the tip of the ClearFlash AC2100 device to the skin area and pressing a pulse activation button that releases a controlled amount of thermal energy into the skin. After the pulse is delivered to the skin the ClearFlash AC2100 device is removed from the acne lesion and the treatment is complete. The treated area on the skin can then be cleaned with an over-thecounter astringent. The ClearFlash AC2100 device is powered by a 9V battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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
Laboratory bench top testing demonstrated that the ClearFlash AC2100 device performed similarly to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
ThermaClear Device (K060653), Zeno Acne Device (K043377), Radiancy ClearTouch Lite (K060411)
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
KII 1937-
FEB - 8 2012
510(k) Summary 5.
ClearFlash, Incorporated - ClearFlash AC2100 Cosmetic System
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
| Owner Name and Address | ClearFlash Technologies, Inc.
901 South Mopac Expressway
Barton Oaks Plaza One, Suite 300
Austin, TX 78746
(949) 949-295-6594 (Phone)
(949) 334-0089 (Fax) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Info | Joseph Neev
2706 S. La Paz Rd. #108
Aliso Viejo, CA 92656-3041
(949) 295-6594 (Phone)
(949) 334-0089 (Fax) |
| Date Prepared | June 30th, 2011 |
| Device Trade Name | ClearFlash AC2100 Cosmetic System |
| Common Name | Acne Treatment Device |
| Classification Name | Class II - Laser instrument, surgical, powered (21 CFR 878.4810,
Product Code OLP) |
| Predicate Devices and
510(k) Numbers | ThermaClear Device (K060653) |
| | Zeno Acne Device (K043377) |
| | Radiancy ClearTouch Lite (K060411) |
1
Description of Device The ClearFlash AC2100 is a compact, handheld device that delivers a controlled pulse of thermal energy to the skin for treating dermatological disorders, specifically, mild to moderate inflammatory acne. An acne lesion is treated by applying the tip of the ClearFlash AC2100 device to the skin area and pressing a pulse activation button that releases a controlled amount of thermal energy into the skin. After the pulse is delivered to the skin the ClearFlash AC2100 device is removed from the acne lesion and the treatment is complete. The treated area on the skin can then be cleaned with an over-thecounter astringent. The ClearFlash AC2100 device is powered by a 9V battery. The ClearFlash AC2100 Cosmetic System is indicated for the Indications for Use treatment of individual acne pimples in persons with mild to moderate inflammatory acne. Performance Data Laboratory bench top testing demonstrated that the ClearFlash AC2100 device performed similarly to the predicate devices. Substantial Equivalence The ClearFlash AC2100 and predicate devices deliver thermal energy into the skin through different methods to treat mild to moderate inflammatory. Minor differences in the technological characteristics of the ClearFlash AC2100 device compared to predicate devices does not raise any new safety or efficacy issues. Therefore, the ClearFlash AC2100 device is substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, Conclusion performance testing and comparisons to predicate devices, the ClearFlash AC2100 has been shown to be safe and effective for its
intended use.
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 stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 8 2012
ClearFlash Technologies, Inc. % Mr. Joseph Neev Regulatory Consultant to CFT, Inc. 2706 S. La Paz Road, #108 Aliso Viejo, California 92656-3041
Re: K111937
Trade/Device Name: ClearFlash AC2100 Cosmetic System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OLP Dated: January 19, 2012 Received: January 23, 2012
Dear Mr. Neev:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2 - Mr. Joseph Neev
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkersof Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement 4.
| 510(k) Number (if known): | K111937 |
|---|---|
| Device Name: | ClearFlash AC2100 Cosmetic System |
| Indications for Use: | The ClearFlash AC2100 Cosmetic System is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne. |
Prescription Use ____________ AND/OR Over-The Counter Use ____________ X
(Part 21 CFR 801 Subpart D) (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)
NelfROgden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111937