(91 days)
Not Found
No
The device description details a light therapy device with analog controls and a fan for thermal management. There is no mention of any computational or adaptive elements that would suggest AI/ML. The performance comparison is based on a predicate device, not on the analysis of data by the device itself.
Yes
The device is indicated for "treatment of moderate inflammatory acne vulgaris," which is a dermatological condition. Therapeutic devices are used in the treatment, cure, mitigation, or prevention of disease.
No
The device description indicates it uses LED lights to treat moderate inflammatory acne vulgaris, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines hardware components such as LED panels, a fan, an aluminum heat sink, a mechanical arm, and an analog timing device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of moderate inflammatory acne vulgaris." This is a therapeutic application, not a diagnostic one.
- Device Description: The device uses LED light to treat a condition. It does not involve analyzing samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting specific analytes (e.g., proteins, DNA, antibodies).
- Providing diagnostic information.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The AcneLift device directly treats a condition using light therapy.
N/A
Intended Use / Indications for Use
AcneLift" is generally indicated for the treatment of dermatological conditions and specifically indicated for the treatment of moderate inflammatory acne vulgaris.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
AcneLift uses panels of LED's which emit visible light of 407 ± 5 nm and is not associated with the risks or harmful side effects of ultraviolet radiation. Thermal Management is achieved by a fan mounted in close proximity to an aluminum heat sink. The lights are mounted to a mechanical arm and are controlled by an analog timing device. The treatment area is approximately 960 cm4 The total light emitted is 42 Watts giving a fluence of about 45 mW/cm2. Thus, AcneLift provides 50 Joules/cm of energy, in approximately 18-20 minutes.
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)
Based on analysis of performance characteristics of Omnilux Blue and AcneLift, Inneract LLC does not believe that any significant differences exist. Therefore, the AcneLift device does not impose any new safety or effectiveness concerns.
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.
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
K041103 1 of 2
FDA 510 K Summary of Safety and Effectiveness for AcneLift
1. General Information
| Submitter: | Inner Act, LLC
4750 Turbo Circle
Reno, Nevada 89502
775-829-2566
Fax: 775-829-7588 |
|---------------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Ronnie Lamberton MD
At above address, cell: 909-378-9536 |
| Summary Preparation Date: | April 12, 2004 |
2. Names
| Device Name: | AcneLift |
|---|---|
| Classification Name: | Laser instrument, surgical, powered device; GEX |
| Class II category. |
Predicate Device 3.
AcneLift is substantially equivalent to the Omnilux Blue (K030883)
Device Description 4.
AcneLift uses panels of LED's which emit visible light of 407 ± 5 nm and is not associated with the risks or harmful side effects of ultraviolet radiation. Thermal Management is achieved by a fan mounted in close proximity to an aluminum heat sink. The lights are mounted to a mechanical arm and are controlled by an analog timing device. The treatment area is approximately 960 cm4 The total light emitted is 42 Watts giving a fluence of about 45 mW/cm2. Thus, AcneLift provides 50 Joules/cm of energy, in approximately 18-20 minutes.
Indications for Use 5.
AcneLift " is generally indicated for treatment of dermatological conditions and specifically indicated for the treatment of moderate inflammatory acne vulgaris.
Performance Data 6.
Based on analysis of performance characteristics of Omnilux Blue and AcneLift, Inneract LLC does not believe that any significant differences exist. Therefore, the AcneLift device does not impose any new safety or effectiveness concerns.
1
K041103 2 of 2
"Software"
AcneLift T" does not use any software programs. The treatment time, is controlled by a digital timer which turns off the LED's after the selected time interval.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2004
Ronald W. Lamberton, M.D. Medical Director of Research and Development Inner Act. LLC 4750 Turbo Circle Reno, Nevada 89502
Re: K041103
Trade/Device Name: AcneLift 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 12, 2004 Received: May 20, 2004
Dear Dr. Lamberton:
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.
3
Page 2 - Ronald W. Lamberton, M.D.
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
{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
4
Indications for Use
510(k) Number (if known): _K041103
Device Name: AcneLift
Indications For Use:
AcneLift" is generally indicated for the treatment of dermatological conditions and specifically indicated for the treatment of moderate inflammatory acne vulgaris.
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 Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041103