(24 days)
Not Found
No
The description focuses on manual operator control and does not mention any AI/ML components or capabilities.
Yes.
The device is intended to treat various medical conditions, including benign vascular and pigmented lesions, permanent hair reduction, and different types of acne. This aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
The device is intended for treatment (e.g., permanent hair reduction, acne treatment) using intense pulsed light, not for diagnosing conditions.
No
The device description clearly states it is a "portable tabletop system" consisting of a "main console, a treatment handpiece and a footswitch," indicating it is a hardware device that delivers intense pulsed light.
Based on the provided information, the Isolaz™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating various skin conditions (vascular and pigmented lesions, hair reduction, acne) by applying intense pulsed light. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system that delivers light energy to the skin. This aligns with a therapeutic device, not one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) or to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The Isolaz™ device's function is to directly treat the patient's skin.
N/A
Intended Use / Indications for Use
The Isolaz™ is intended to treat benign vascular and pigmented lesions, permanent hair reduction, mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).
Product codes
GEX
Device Description
The Isolaz™ System is a portable tabletop system used to deliver non-coherent 400-1200nm, 530-12000mm and 580-1200mm intense pulsed light via a delivery handpiece utilizing photpneumatic technology. The system consists of a main console, a treatment handpiece and a footswitch. The desired power and delivery time are set manually by the operator.
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
Product testing was conducted to evaluate conformance to product specification. The results showed the system met specification.
Key Metrics
Not Found
Predicate Device(s)
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.
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JAN - 9 2009
Section 5
510(k) Summary
General Information Classification
Trade Name
Submitter
Contact
Class II
Isolaz™ Intense Pulsed Light System
Aesthera 6634 Owens Drive Pleasanton, CA 94588 877 275 4779 Tel: 925 737 2197 Fax:
Pamela M. Buckman, MSN Consultant Buckman Company, Inc. 1070 Concord Ave., Suite 230 Concord, CA 94520 Tel: 925 980 7007 925 356 2654 Fax:
Intended Use
The Isolaz™ is intended to treat benign vascular and pigmented lesions, permanent hair reduction, mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).
Predicate Devices
Aesthera Photopneumatic PPx™ System K062048
Device Description
The Isolaz™ System is a portable tabletop system used to deliver non-coherent 400-1200nm, 530-12000mm and 580-1200mm intense pulsed light via a delivery handpiece utilizing photpneumatic technology. The system consists of a main console, a treatment handpiece and a footswitch. The desired power and delivery time are set manually by the operator.
Materials
All materials used in the manufacture of the Isolaz™ are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was conducted to evaluate conformance to product specification. The results showed the system met specification.
Summary of Substantial Equivalence
The Isolaz™ System is equivalent to the predicate product. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract symbol of an eagle, with its wings spread and head turned to the left. The eagle is composed of thick, black lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 2009
Aesthera Corporation % Buckman Company, Inc. Ms. Pamela M. Buckman, MSN President 1070 Concord Avenue, Suite 230 Concord, California 94520
Re: K083730
Trade/Device Name: Isolaz™ 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: December 15, 2008 Received: December 16, 2008
Dear Ms. Buckman:
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
2
Page 2 - Ms. Pamela M. Buckman, MSN
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 H Millican
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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Section 4
Indications for Use Statement
510(k) Number:
K 083730 Pending.
Isolaz™ System
Device Name:
Indications for Use:
The Isolaz™ System is designed to treat benign vascular and pigmented lesions, permanent hair reduction, mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).
X Prescription Use (Per 21 CFR 801 Subpart D)
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)
OR
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Page 7 of 18