(195 days)
Not Found
No
The description focuses on light energy technology and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the "treatment of individual acne pimples," which signifies a therapeutic purpose.
No
The device is indicated for the "treatment" of acne, not for diagnosis.
No
The device description explicitly states it is a "portable handheld device that uses light energy from the blue to infra-red spectrum emitted by a Xenon flash lamp" and is "powered by a rechargeable battery," indicating it is a physical hardware device.
Based on the provided information, the CLARO device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the CLARO is for the treatment of acne pimples using light energy. IVDs are used to diagnose diseases or conditions by examining samples from the human body (like blood, urine, or tissue).
- Device Description: The description details a portable handheld device that emits light energy for therapeutic purposes. This is consistent with a medical device used for treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The CLARO is clearly described as a therapeutic device for treating acne.
N/A
Intended Use / Indications for Use
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Product codes
GEX
Device Description
The CLARO is a portable handheld device that uses light energy from the blue to infra-red spectrum emitted by a Xenon flash lamp. The device is powered by a rechargeable battery. CLARO is intended to be a prescription device which will be used both in the doctor's office and in the home environment for the treamment of mild to moderate acne.
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
will be used both in the doctor's office and in the home environment
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)
Performance testing will be performed which will demonstrate compliance with IEC 60601-1-1 and IEC 60601-1-2.
Testing was submitted which showed that the user was able to use the device in the home-use environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060411, K043377, K060653, K040081, K041086, K0511113
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
080636 SEP 1 7 2008
510(k) Summary for the CLARO
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
-
- General Information
Submitter:
- General Information
CLRS Technology Corporation 3183 A-1 Airway Ave. Costa Mesa, CA 92626
Contact Person:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
Summary Preparation Date:
March 4, 2008
- Names
Device Name:
Classification Name:
CLARO
Laser surgical instrument for use in general and plastic surgery and in dermatology
Product Code: GEX
3. Predicate Devices
The CLARO is substantially equivalent to a combination of the Radiancy Clear Touch Lite Acne Clearance System (K060411), the Tyrell, Incorporation Zeno Acne Device (K043377) the DermaCare, Inc. ThermaClear Device (K060653), the Palomar StarLux with LuxV Handpiece (K040081 and K041086), and the Quanta System Eterna Giovinezza System (K0511113).
4. Device Description
The CLARO is a portable handheld device that uses light energy from the blue to infra-red spectrum emitted by a Xenon flash lamp. The device is powered by a rechargeable battery. CLARO is intended to be a prescription device which will be used both in the doctor's office and in the home environment for the treamment of mild to moderate acne.
1
pg 2 of 2
5. Indications for Use
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
6. Performance Data
Performance testing will be performed which will demonstrate compliance with IEC 60601-1-1 and IEC 60601-1-2.
Testing was submitted which showed that the user was able to use the device in the home-use environment.
2
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 depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
SEP 1 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CLRS Technology Corporation % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864
Rc: K080638 Trade/Device Name: CLARO 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: September 12, 2008 Received: September 17, 2008
Dear Ms. O'Connell:
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 mav 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 - Ms. Maureen O'Connell
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millman
Mark N. Melkerson Director Division of General, Restorative .and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
pg 1 of 1
6080638 510(k) Number (if known):
Device Name: CLARO
Indications For Use:
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K080638