(140 days)
Not Found
No
The description focuses on laser technology and an embedded processor for control, with no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is used for medical procedures to treat various dermatological conditions and improve skin health, which aligns with the definition of a therapeutic device.
No
The device description and indications for use clearly describe a therapeutic laser system used for various dermatological treatments, not for diagnosing conditions.
No
The device description explicitly states it is a "Laser System" consisting of laser sources, fiber delivery, and scanning/focusing optics, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a laser system used for dermatological procedures directly on the patient's skin. It delivers thermal energy to the epidermis and dermis for treatment purposes, not for analyzing biological samples.
The description clearly indicates it's a therapeutic device used for treating various skin conditions and performing skin resurfacing, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
1550 nm: The Fraxel 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 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
Product codes
GEX
Device Description
The Fraxel DUAL 1550/1927 nm 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
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
A clinical study was conducted to support a determination of substantial equivalence to the predicate device, the Fraxel DUAL 1550/1927 Laser System (K101490). The clinical performance data confirmed that the Fraxel DUAL 1550/1927 Laser System performs as intended and that the expansion of the new 1927 nm indications do not raise new issues of safety and effectiveness.
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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SECTION 5: 510(k) SUMMARY STATEMENT
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92
1. General Information
Date of Submission: January 25, 2013
Submitted By:
Solta Medical, Inc. 25881 Industrial Blvd. Hayward, CA 94545
Contact Person:
Raymond Lee Sr. Director, Regulatory Affairs 510-259-7159 (Direct Phone) 510-780-4931 Fax rflee@solta.com
2. Trade/Proprietary Name of Device:
| Trade Name: | Fraxel® DUAL 1550/1927 Laser System |
|---|---|
| Common Name: | Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product Code: | GEX |
| Device Panel: | General Surgery/Restorative Devices |
| Device Classification: | Class II |
3. Legally Marketed Predicate Devices for Claimed Equivalence:
Fraxel® DUAL 1550/1927 Laser System Name: 510(k) #: K101490
Fraxel® Re:fine Laser System Name: 510(k) #: K063808
4. Device Description
The Fraxel DUAL 1550/1927 nm 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.
1
5. Indications for Use Statement
1550 nm: The Fraxel 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 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
6. Substantial Equivalence Comparison
Indications for Use
Substantial equivalence for the Fraxel DUAL 1550/1927 nm Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indications statements. Clinical performance data confirmed that the Fraxel DUAL 1550/1927 nm Laser System performs as intended and that no new issues of safety and effectiveness are introduced.
Technological Characteristics
Key technological characteristics of the Fraxel DUAL 1550/1927 nm Laser System, such as energy type and operating principle, are identical to the Fraxel DUAL 1550/1927 nm Laser System described in submission K101490. No changes were made to the mode of operation and fractional delivery of the 1550 and 1927 nm laser sources.
Performance Data
A clinical study was conducted to support a determination of substantial equivalence to the predicate device, the Fraxel DUAL 1550/1927 Laser System (K101490). The clinical performance data confirmed that the Fraxel DUAL 1550/1927 Laser System performs as intended and that the expansion of the new 1927 nm indications do not raise new issues of safety and effectiveness.
Substantial Equivalence Statement
When compared to the predicate devices, the additional indications for use of the Fraxel Dual 1550/1927 Laser System do not raise new issues of safety and effectiveness.
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K130193
Therefore, based on the similarities in technological features, mode of operation, laser-tissue interaction, clinical performance, and intended use, the modified Fraxel DUAL 1550/1927 Laser System is substantially equivalent to the predicate devices marketed under the Federal Food, Drug and Cosmetic Act.
7. Conclusion
The Fraxel DUAL 1550/1927 nm Laser System is substantially equivalent to the predicate devices currently marketed in accordance with the Federal Food, Drug and Cosmetic Act. Based on clinical performance data, the addition to the indications for use raises no new safety and effectiveness questions.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 14, 2013
Solta Medical, Inc. % Mr. Raymond Lee Senior Director, Regulatory Affairs 25881 Industrial Boulevard Hayward, California 94545
Re: K130193
Trade/Device Name: Fraxel Dual 1550/1927 nm Laser System 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: GEX Dated: April 17, 2013 Received: April 18, 2013
Dear Mr. Lee:
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.
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
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Page 2 - Mr. Raymond Lee
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FOR
Peter D. Rumm-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K130193 510(k) Number (if known):
Device Name: Fraxel DUAL 1550/1927 nm Laser System and Accessories
Indications For Use:
1550 nm: The Fraxel 1550 mm 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 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actimic keratosis, and treatment of pigmented lessons such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).
Prescription Use X (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)
Neil R Ogdent 2013.06.13 115:57:49 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
K130193 510(k) Number_
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