(99 days)
Not Found
No
The document describes a laser system with an embedded processor for control, but there is no mention of AI, ML, or image processing capabilities. The performance studies focus on the laser's effect on tissue and clinical outcomes, not on algorithmic performance.
Yes
The device is indicated for the treatment of various medical conditions, including dyschromia, cutaneous lesions, actinic keratosis, melasma, periorbital wrinkles, acne scars, and surgical scars. These are therapeutic applications.
No
The device description and intended use indicate that the Fraxel re:store Dual Laser System is used for therapeutic dermatological procedures such as tissue coagulation, skin resurfacing, and the treatment of various skin conditions and lesions, not for diagnosing them.
No
The device description explicitly states it consists of laser sources, fiber delivery, scanning and focusing optics, and accessories, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Fraxel re:store Dual Laser System is a laser device used for dermatological procedures. It delivers thermal energy to the skin for treatment purposes (coagulation, resurfacing, treating lesions and wrinkles). This is a direct treatment applied to the body, not a test performed on a sample from the body.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Fraxel re:store Dual Laser System falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
1550 nm: The Fraxel re:store® Dual 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.
Product codes (comma separated list FDA assigned to the subject device)
ONG, GEX
Device Description
The Fraxel re:store® Dual Laser System consists of a 1550 nm laser source and a 1927 nm laser source with fiber delivery and control by an embedded processor for use in dermatological procedures. The laser system uses scanning and focusing optics to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, epidermis and dermis for dermatological procedures.
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)
Pre-clinical Studies
Histological analysis of lesion characteristics (depth and width) created by the 1927 nm wavelength laser in pig skin and excised human abdominal tissue (included in the original Fraxel re:store Dual submission K091420) demonstrated the safety of this wavelength in treating the added indication of actinic keratosis.
Clinical Studies
In clinical studies, safety and efficacy of the 1927 nm wavelength in the treatment of actinic keratosis was demonstrated, and side effects were minimal and well tolerated.
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.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
DATE OF SUBMISSION
September 7, 2010
REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT
Kristine Foss Solta Medical, Inc. 25881 Industrial Blvd Hayward, CA 94545 510-780-4657 phone 510-780-4857 fax kfoss@solta.com
NAME OF DEVICE
Trade Name:
| Common Name: | |
|---|---|
| Regulation Number | |
| Product code: | |
| Device Panel: | |
| Device Classification: |
Fraxel re:store® Dual Laser System and Accessories Laser Surgical Instrument 878.4810 GEX General Surgery/Restorative Devices Class II
LEGALLY MARKETED PREDICATE DEVICES
Name: Fraxel re:store Laser System and Accessories 510(k) #: K060310
Name: Fraxel re:store® Dual Laser System and Accessories 510(k) #: K091420
1101490 SEP 0 8 2010
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DEVICE DESCRIPTION
The Fraxel re:store® Dual Laser System consists of a 1550 nm laser source and a 1927 nm laser source with fiber delivery and control by an embedded processor for use in dermatological procedures. The laser system uses scanning and focusing optics to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.
INDICATION FOR USE STATEMENT
Indications for use:
1550 nm: The Fraxel re:store® Dual 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.
SUBSTANTIAL EQUIVALENCE COMPARISON
Indications for Use
Substantial equivalence for the Fraxel re:store® Dual Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements. Histological and clinical performance data confirmed that the Fraxel re:store Dual® Laser System performs as intended and that no new issues of safety and effectiveness are introduced.
Technological Characteristics
Key technological characteristics of the Fraxel re:store® Dual Laser System, such as energy type and operating principle, are identical to the Fraxel re:store® Dual Laser System described in submission K091420. In particular, the 1550 nm and 1927 nm laser sources and delivery systems are identical. Energy is delivered through the same handpiece for both systems. There are no changes in system software or user interface for the Fraxel re:store® Dual Laser System, which is the subject of this submission, and the device of the predicate submission K091420.
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Pre-clinical and Clinical Studies
Pre-clinical Studies
Histological analysis of lesion characteristics (depth and width) created by the 1927 nm wavelength laser in pig skin and excised human abdominal tissue (included in the original Fraxel re:store Dual submission K091420) demonstrated the safety of this wavelength in treating the added indication of actinic keratosis.
Clinical Studies
In clinical studies, safety and efficacy of the 1927 nm wavelength in the treatment of actinic keratosis was demonstrated, and side effects were minimal and well tolerated.
CONCLUSION
Based on the evaluation described within, the Fraxel re:store® Dual Laser System is substantially equivalent to the predicate devices currently marketed in accordance with the Federal Food, Drug and Cosmetic Act. Safety and effectiveness were reasonably assured, justifying 510(k) clearance.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol, with three lines forming a shape resembling a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Solta Medical, Inc. % Ms. Kristine Foss Vice President, Regulatory, Clinical and Quality 25881 Industrial Boulevard Hayward, California 94545
SEP 0 8 2010
Re: K101490
Trade/Device Name: Fraxel re:store® Dual Laser System and Accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and Plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONG Dated: August 19, 2010 Received: August 23, 2010
Dear Ms. Foss:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Kristine Foss
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkersor Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
SEP 0 8 2010
510(k) Number K101490:
Device Name: Fraxel re:store® Dual Laser System and Accessories
Indications for use:
1550 nm: The Fraxel re:store 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.
Prescription Use × (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/onDevice Evaluation (ODE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number