← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K070284 # FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) (K070284) _Reliant Technologies, Inc. · GEX · May 17, 2007 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K070284 ## Device Facts - **Applicant:** Reliant Technologies, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** May 17, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Fraxel® SR 1500 Laser System and accessories is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical scars; Photocoagulation for treatment of dyschromia and pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis and melasma; Skin resurfacing procedures. ## Device Story Fiber laser system; delivers controlled thermal energy to epidermis and dermis via scanning and focusing optics; used in dermatology clinics by physicians; treats wrinkles, scars, dyschromia, and lesions; provides skin resurfacing; embedded processor controls laser delivery; output is thermal coagulation; benefits include improved skin texture and appearance. ## Clinical Evidence No clinical data provided; substantial equivalence based on identical technological characteristics and indications for use to previously cleared predicate devices. ## Technological Characteristics Fiber laser system; scanning and focusing optics; embedded processor control; energy type and operating principle identical to K062303; accessories include tip kits and pre-treatment solution. ## Regulatory 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. ## Predicate Devices - Fraxel® II SR Laser System and Accessories ([K062303](/device/K062303.md)) - Fraxel® II SR Laser System and Accessories ([K060310](/device/K060310.md)) - Fraxel® SR Laser System and Accessories ([K050841](/device/K050841.md)) - Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories ([K022060](/device/K022060.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 070284 ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS #### REGULATORY AUTHORITY Safe Medical Devices Act of 1990, 21 CFR 807.92 COMPANY NAME/CONTACT Heather Tanner MacFalls Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 605-2257 phone 650 605-2057 fax hmacfalls@fraxel.com #### NAME OF DEVICE Trade Name: Common Name: Regulation Number Product code: Device Panel: Device Classification: Fraxel® SR1500 Laser System and Accessories Laser Surgical Instrument 878.4810 GEX General Surgery/Restorative Devices Class II # LEGALLY MARKETED PREDICATE DEVICES Name: Fraxel® II SR Laser System and Accessories 510(k) #: K062303 Name: Fraxel® II SR Laser System and Accessories 510(k) #: K060310 Name: Fraxel® SR Laser System and Accessories 510(k) #: K050841 Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060 #### DEVICE DESCRIPTION The Fraxel® SR1500 Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics MAY 1 7 2007 {1}------------------------------------------------ # 070284 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 The Fraxel® SR1500 Laser System is intended for use in: Dermatological procedures requiring the coagulation of soft tissue: Treatment of periorbital wrinkles; Treatment of acne scars and surgical scars; Photocoagulation for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma: Skin resurfacing procedures. # SUBSTANTIAL EQUIVALENCE COMPARISON #### Indications for Use Substantial equivalence for the Fraxel® SR1500 Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements. The clinical performance data reviewed supported the determination that the Fraxel® SR1500 Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced. #### Technological Characteristics Key technological characteristics of the Fraxel® SR1500 Laser System, such as energy type and operating principle, are identical to the Fraxel® SR1500 Laser System as described in submission K062303. #### CONCLUSION Based on the evaluation described herewithin, the Fraxel® SR1500 Laser System and Accessories 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. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Reliant Technologies, Inc. % Ms. Heather MacFalls Director of Regulatory and Clinical Affairs 464 Ellis Street Mountain View, California 94043 MAY 1 7 2007 Re: K070284 Trade/Device Name: Fraxel® SR 1500 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: II Product Code: GEX Dated: April 12, 2007 Received: May 4, 2007 Dear Ms. MacFalls: 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. {3}------------------------------------------------ Page 2 -- Ms. Heather MacFalls 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. y yours. Mark N. Mull M rk N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): ヒロフロスタイ Fraxel® SR 1500 Laser System and accessories Device Name:___ Indications For Use: "The Fraxel® SR 1500 Laser System and accessories is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical scars; Photocoagulation for treatment of dyschromia and pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis and melasma; Skin resurfacing procedures." 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 of Device Evaluation (ODE) | (Division Sign-Off) | | |------------------------------------------------------------|-------------------| | Division of General, Restorative, and Neurological Devices | Page 1 of _______ | | 510(k) Number | L070284 | --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K070284](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K070284) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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