(49 days)
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No
The document describes a photopneumatic system utilizing intense pulsed light and does not mention any AI or ML components or capabilities.
Yes
The device is intended for the treatment of various medical conditions such as benign vascular and pigmented lesions, permanent hair reduction, and mild to moderate acne. These uses directly address health concerns, classifying it as a therapeutic device.
No
The device description indicates that the Aesthera Photopneumatic™ (PPx™) System is used to "deliver intense pulsed light to the patient treatment site," which describes a therapeutic function rather than a diagnostic one. Its indicated uses are treatments for skin conditions and hair reduction, not for diagnosing them.
No
The device description clearly outlines multiple hardware components including a main console, treatment handpiece, optional coolant accessory, and treatment footswitch. This indicates it is a hardware-based system, not software-only.
Based on the provided information, the Aesthera Photopneumatic™ (PPx™) System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed are for treating skin conditions (vascular and pigmented lesions, hair reduction, acne). These are treatments applied directly to the patient's body, not tests performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a system that delivers intense pulsed light to the patient's skin. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect biomarkers, or provide diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Aesthera Photopneumatic™ (PPx™) System is a therapeutic device used for treating certain skin conditions.
N/A
Intended Use / Indications for Use
The Aesthera Photopneumatic™ (PPx™) System is intended for:
- The treatment of benign vascular and pigmented lesions; .
- Permanent hair reduction; .
- The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild . to moderate inflammatory acne (acne vulgaris).
The Aesthera Photopneumatic™ (PPx™) System is intended for use on all skin types (Fitzpatrick skin types I-VI).
Product codes
GEX
Device Description
The Aesthera Photopneumatic™ (PPx™) System is comprised of the following main components:
- . Main console
- PPx™ Treatment Handpiece .
- Optional coolant accessory cryogenic, water, or air spray for cooling the handpiece . tip; and
- . Treatment Footswitch.
The Aesthera Photopneumatic™ (PPx™) System (with treatment handpiece) is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing Photopneumatic technology. Intense pulsed light is emitted through the IntelliTip™ only when the tip is sealed against the selected patient treatment All emitted light is contained within the IntelliTip™ during treatment. site. The handpiece is uniquely designed to promote increased ergonomics with all user interface and controls located on the handpiece.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data demonstrating the safety and effectiveness of the Aesthera Photopneumatic™ (PPx™) System for the treatment of mild to severe acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris) was provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
K041554, K051268, K052442, K060411, K040081, K041086, K043319
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the numbers '062048'. The characters and numbers are written in a handwritten style, with varying thickness and spacing.
SEP - 7 2006
Section 5 - 510(k) Summary or Stock) Statement
I. General Information
Submitter:
Aesthera Corporation 6634 Owens Drive Pleasanton, CA 94588 USA
Contact Person:
Chief Technical Officer
Robert Anderson
Summary Preparation Date: July 18, 2006
II. Names
Device Names: Aesthera Photopneumatic™ (PPx™) System
Primary Classification Names: Accessory for, Laser Powered Surgical Instruments
III. Predicate Devices
- Aesthera AIP Intense Pulsed Light System (K041554); .
- Radiancy Acne System with ClearTouch Light Unit Assembly (K051268); .
- Radiancy Skin Station with Modified Light Unit Assembly for Psoriasis System . (K052442);
- . Radiancy ClearTouch Lite Acne Clearance System (K060411);
- Palomar Lux V Pulsed Light Handpiece for StarLux Systems (K040081); .
- � Palomar StarLux Pulsed Light System (K041086);
- Novalis Clareon & Solarus Pulsed Light Systems w/ AR Handpiece (K043319) �
IV. Product Description
The Aesthera Photopneumatic™ (PPx™) System is comprised of the following main components:
- . Main console
- PPx™ Treatment Handpiece .
- Optional coolant accessory cryogenic, water, or air spray for cooling the handpiece . tip; and
- . Treatment Footswitch.
The Aesthera Photopneumatic™ (PPx™) System (with treatment handpiece) is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing Photopneumatic technology. Intense pulsed light is emitted through the IntelliTip™ only when the tip is sealed against the selected patient treatment All emitted light is contained within the IntelliTip™ during treatment. site. The handpiece is uniquely designed to promote increased ergonomics with all user interface and controls located on the handpiece.
1
V. Indications for Use
The Aesthera Photopneumatic™ (PPx™) System is intended for:
- The treatment of benign vascular and pigmented lesions: .
- Permanent hair reduction; .
- The treatment of mild to moderate acne, including pustular acne, comedonal acne, . and mild to moderate inflammatory acne (acne vulgaris).
The Aesthera Photopneumatic™ (PPx™) System is intended for use on all skin types (Fitzpatrick skin types I-VI).
Rationale for Substantial Equivalence VI.
The Aesthera Photopneumatic™ (PPx™) System shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
Safety and Effectiveness Information VII.
The review of the indications for use and technical characteristics and the published medical literature provided demonstrates that the Aesthera Photopneumatic™ (PPx™) System is substantially equivalent to the predicate devices. Clinical data demonstrating the safety and effectiveness of the Aesthera Photopneumatic™ (PPx™) System for the treatment of mild to severe acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris) was provided.
VIII. Conclusion
The Aesthera Photopneumatic™ (PPx™) System was found to be substantially equivalent to the predicate devices.
The Aesthera Photopneumatic™ (PPx™) System shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, well-being, and human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2006
Aesthera Corporation % AL Voss Associates Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566
Re: K062048
Trade/Device Name: Aesthera Photopneumatic™ (PPx"") 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: July 18, 2006 Received: July 20, 2006
Dear Ms. Worden:
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
3
Page 2 -- Ms. Anne Worden
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for Palo Shup
N. Melkerson
Mark N. Melkerson 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 Statement
510(k) Number (if known): K062048
Device Name: Aesthera PhotopneumaticTM (PPxTM) System
Indications for Use:
The Aesthera Photopneumatic™ (PPx™) System is intended for:
- The treatment of benign vascular and pigmented lesions; .
- Permanent hair reduction; .
- The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild . to moderate inflammatory acne (acne vulgaris).
The Aesthera Photopneumatic™ (PPx™) System is intended for use on all skin types (Fitzpatrick skin types I-VI).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices a
510(k) Number K062048