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  1. www.accessdata.fda.gov › cdrh_docs › pdf10510(k) SUMMARY OF SAFETY AND EFFECTI VENESS DATE OF ...

    The Fraxel re~store® Dual Laser System consists of a 1550 nm. laser source and a 1927 rnm laser source with fiber delivery and control by an embedded processor for use in dermatological...

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  2. www.accessdata.fda.gov › scripts › cdrh510(k) Premarket Notification - Food and Drug Administration

    2024年7月8日 · FRAXEL DUAL 1550/1927 LASER SYSTEM Applicant SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD HAYWARD, CA 94545 ... (1-888-463-6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research ...

  3. skindr.com.tw › beauty › display飛梭雷射全攻略！縮毛孔效果好嗎？要打幾次？價格/術後照顧...

    Fraxel飛梭雷射經FDA認證，能去除老化與不平順的皮膚，將凹疤與皺紋撫平，達到深層換膚，讓毛孔、疤痕問題一網打盡。. 優點是可以取代雷射磨皮，術後恢復期短，生活不受影響，新一代Fraxel®飛梭雷射是利用波長1540nm與1550nm奈米級的雷射光，以無數點狀方式 ...

  4. www.prnewswire.com › news-releases › solta-medical-announcesSolta Medical Announces FDA 510(k) Clearance of Fraxel ...

    2010年9月16日 · As the leader in fractional laser technology, Fraxel delivers minimally invasive clinical solutions to resurface aging and sun damaged skin. Isolaz is the only laser or light based system...

  5. www.fraxel.comFraxel | Skin Resurfacing Treatment

    Fraxel ® 1927nm wavelength is indicated for skin resurfacing including for the treatment of actinic keratosis (pre-cancerous skin lesions); treatment of pigmented lesions, such as age spots, sun spots, and freckles.

  6. www.dermatologytimes.com › view › fda-approves-fraxel-melasmaFDA approves Fraxel for melasma treatment - Dermatology Times

    2005年9月6日 · Palo Alto, Calif. -- The Food and Drug Administration (FDA) has approved Fraxel, a skin-resurfacing laser device manufactured by Reliant Technologies, for use in the treatment of melasma associated with pregnancy, female hormonal activity and certain drugs.

  7. www.prnewswire.com › news-releases › fraxel-dual-laser-systemFraxel® Dual Laser System Receives New FDA 510(k) ...

    2013年6月20日 · The Fraxel DUAL system is an unsurpassed breakthrough skin resurfacing technology that renews skin and helps maintain skin's youthful glow despite a person's age or skin color, with minimal...