(321 days)
Not Found
No
The document does not mention AI, ML, or related concepts like training/test sets, performance metrics associated with AI/ML, or image processing in a way that suggests AI/ML is used for analysis or decision-making. The "intelligent tip" likely refers to a hardware or sensor-based feature, not AI/ML.
Yes
The device is described as treating benign vascular and pigmented lesions, and reducing hair, which are therapeutic applications.
No
The device is described as an Intense Pulsed Light System intended for treatment (benign vascular and pigmented lesions, and permanent hair reduction), not for diagnosis.
No
The device description clearly outlines a physical system including a console, handpiece, and intelligent tip, indicating it is a hardware-based device that utilizes intense pulsed light technology.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of benign vascular and pigmented lesions and permanent hair reduction. IVD devices are used to diagnose or aid in the diagnosis of conditions by examining samples taken from the human body (like blood, urine, tissue).
- Device Description: The description details a light delivery system that applies intense pulsed light to the skin. This is a therapeutic or cosmetic application, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a therapeutic/cosmetic device that uses intense pulsed light for treatment purposes.
N/A
Intended Use / Indications for Use
The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.
The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).
Product codes
GEX
Device Description
The AesThera AIP Intense Pulsed Light System is a 400—1200 nm intense pulsed light delivery system, powered by Photo-Pneumatic™ technology. It is a portable tabletop system with a hand piece connected by an umbilical to the main console. The hand piece incorporates an intelligent tip that is replaced with every patient treatment. A "sealed" intelligent tip is used to transmit light to the patient's skin. Light is emitted only through the tip and is always sealed with the patient's surrounding tissue during intense pulsed light emission. All emitted light is contained within the tip during treatment. The hand niece of the AIP Intense Pulsed Light System is uniquely designed to promote increased ergonomics with all user interface and controls located on the hand piece.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K032205, K033181, K030897, K020856, K992482, K033549, K020941, K020453, K010618, K003886
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
510(k) Summary of Safety and Effectiveness
K041554
This 510(k) Summary of Safety and Effectiveness for the AesThera AIP ™ Intense Pulsed Light 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: | AesThera Corporation
6111 Southfront Road
Suite E
Livermore, CA 94550
Bob Anderson
Chief Financial Officer |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | C. Robert Payne, Jr., P.E.
Regulatory Affairs Consultant
CRP Enterprises
P.O. Box 2608
Morgan Hill, CA 95038
Telephone: (408) 782-3024
Fax: (408) 779-5284
e-mail: myrvhome@ix.netcom.com |
| Preparation Date: | 6 June 2004 |
| Device Trade Name: | AIPTM Intense Pulsed Light System |
| Common Name: | Pulsed Flash Lamp |
| Classification Name: | Surgical instrument for use in general and
plastic surgery and in dermatology
(21 CFR 878-4810) |
| Product Code: | GEX |
| Predicate Devices: | |
- SkinStation™, SPR™, ClearTouch™ , SpaTouch Pro (XtremeClear ™), . SpaTouch ™ (Radiancy (Israel) Ltd.) (K032205, K033181, K030897, K020856, K992482)
- StarLux™, MediLux™, EsteLux™ (Palomar Medical Technologies, Inc.) . (K033549, K020941, K020453, K010618, K003886)
1
Device Description:
The AesThera AIP Intense Pulsed Light System is a 400—1200 nm intense pulsed light delivery system, powered by Photo-Pneumatic™ technology. It is a portable tabletop system with a hand piece connected by an umbilical to the main console. The hand piece incorporates an intelligent tip that is replaced with every patient treatment. A "sealed" intelligent tip is used to transmit light to the patient's skin. Light is emitted only through the tip and is always sealed with the patient's surrounding tissue during intense pulsed light emission. All emitted light is contained within the tip during treatment. The hand niece of the AIP Intense Pulsed Light System is uniquely designed to promote increased ergonomics with all user interface and controls located on the hand piece.
Intended Use of the Device:
The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.
The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).
Substantial Equivalence to Predicate Devices:
The AIP Intense Pulsed Light System, which is intended for the following; the treatment of benign vascular and pigmented lesions, and permanent hair reduction, is substantially equivalent in design and materials to the listed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle, with three stylized lines representing the bird's wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2005
AesThera Corporation C/o C. Robert Payne, Jr., P.E. RA/ QA Consultant CRP Enterprises P.O. Box 2608 Morgan Hill, California 95038
Re: K041554 Trade/Device Name: AIP™ Intense Pulsed Light System 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: March 16, 2005 Received: March 21, 2005
Dear Mr. Payne:
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 - Mr. C. Robert Payne, Jr., P.E.
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.
b
Sincerely yours,
Ron G. Th
Miriam C. Provost, Ph.D. Acting 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
| 510(k) Number: | New submission
NAME OF LOT LIES LOOM | 1 00 | Caroline, and and and the production of | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------|-----------------------------------------|------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
AIP TM Intense Pulsed Light System Device Name:
Indications for Use:
The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.
The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).
Prescription Use X
OR (per 21 CFR 878-4810)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Please do not write below this line - Continue on another page if needed)
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