510(k) Report

Devices descending from K041999

111 later devices reach Gyrus Plasma Skin Resurfacing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060948Portrait PSR3Rhytec Incorporated20061101
+2K071786Portrait PSRRhytec Incorporated2007109—
+3K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+3K072394Portrait Stand-OffRhytec Incorporated2007104—
+4K221873NeoGen PSR SystemEnergist Limited20230—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+5K132754Neogen PSR SystemEnergist, Ltd.20132—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K102461FractoraInvasix, Ltd.201124—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K131758Surgen UPollogen, Ltd.20135—
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K193201BTL-785FBtl20208—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K160312Fraxis DuoIlooda Co,., Ltd.201614—
+7K153717Venus Versa SystemVenus Concept, Ltd.20161—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K211639BTL-785WBTL Industries, Inc.20227—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K192545PotenzaJeisys Medical Incorporated202020—
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K210084SilkroHironic Co., Ltd.20223—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K203728DarwinLuvo Medical Technologies, Inc.20211—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K242688Finiff SystemSkingrab Co., Ltd.20240—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K233123SilkroHironic Co., Ltd.20241—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K233604BTL-785SBTL Industries, Inc.20243—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K233143PiXel8-RevealRohrer Aesthetics20240—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K212607DarwinLuvo Medical Technologies, Inc.20210—
+11K254185Potenza PrimeJeisys Medical Incorporated20260—
+11K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+11K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+11K253803MILAN SystemLumenis Be, Ltd.20260—
+11K253750BTL-785NEHBTL Industries, Inc.20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K251254Ignite RF SystemInMode, Ltd.20260—