(165 days)
No
The description focuses on hardware components and basic programmable logic control, with no mention of AI/ML terms or functionalities.
Yes
The device is described as a "non-invasive treatment of wrinkles and rhytids," which is a therapeutic purpose.
No
The device description states its intended use is for "non-invasive treatment of wrinkles and rhytids," and it is referred to as a "Skin Renewal System," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines multiple hardware components including a user interface, PLC, RF power module, internal electronics, vacuum pump, and a treatment handpiece.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "non-invasive treatment of wrinkles and rhytids." This describes a therapeutic procedure performed on a patient's body, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The description details a system that delivers RF energy to the skin for treatment. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Diagnostic or monitoring purposes.
- Use in a laboratory setting.
Therefore, the Aluma Skin Renewal System is a therapeutic device used for dermatological procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures non-invasive treatment of wrinkles and rhytids.
Product codes
GEI
Device Description
The Aluma Skin Renewal System is a non-invasive, non-ablative unit consisting of a user interface, a programmable logic controller (PLC), an RF power module, internal electronics, a vacuum pump, and a treatment handpiece with interchangeable tips (small and large). The interface allows the selection of treatment parameters by pressing on the treatment buttons; an LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 468 kHz frequency.
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
Dermatologic and General Surgical procedures
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
OCT 2 4 2005
K 051214
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the Aluma™ Skin Renewal System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Lumenis, Inc. |
|---|---|
| Address: | 2400 Condensa Street |
| Santa Clara, CA 95051 | |
| Contact Person: | Connie Hoy |
| Telephone: | |
| Fax: | (408) 764-3303 |
| (408) 764-3500 | |
| Preparation Date: | May 1, 2005 |
| Device Trade Name: | Aluma™ Skin Renewal System |
| Common Name: | Electrosurgical cutting and coagulation and |
| device and accessories | |
| Classification Name: | Device, electrosurgical, cutting and coagulation |
| device and accessories (see CFR 878.4400). | |
| Legally Marketed Predicate Devices: | Thermana Inc |
Thermage, Inc ThermaCool™ TC System (K033942 and K040135) Syneron Medical Ltd., Polaris™ (K031671)
1
The Aluma Skin Renewal System is a non-System Description: invasive, non-ablative unit consisting of a user interface, a programmable logic controller (PLC), an RF power module, internal electronics, a vacuum pump, and a treatment handpiece with interchangeable tips (small and large). The interface allows the selection of treatment parameters by pressing on the treatment buttons; an LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 468 kHz frequency Intended Use of the Device: The Aluma Skin Renewal System is a noninvasive device intended for use in Dermatologic and General Surgical procedures non-invasive treatment of wrinkles and rhytids. Technical characteristics; The technological characteristics of the Aluma Skin Renewal System are the same or very similar to those of the claimed predicate devices. Summary: Based on the foregoing, the Aluma Skin Renewal System is substantially equivalent to the legally marketed, claimed predicate devices for the purposes of this 510(k) submission.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Public Health Service
OCT 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Connie Hoy Global Director, RA/QS Lumenis, Incorporate 2400 Condensa Street Santa Clara, California 95051
Re: K051214
Trade/Device Name: Aluma Skin Renewal System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 22, 2005 Received: August 23, 2005
Dear Ms. Hoy:
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
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Barbara Buchner
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) Number:
Device Name:
Aluma Skin Renewal System
Indications for Use:
The Aluma Skin Renewal System is intended for use in Dermatologic and The Anama UKIN Keneral Systems of the non-invasive treatment of wrinkles and rhytids.
(Please do not write below this line – Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR (per 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
charlene mello
Division Sign Off
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K051214 11