510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Quanta System Inc.

SAMARATE Varese, IT

QUANTA SYSTEM INC. appears in FDA device records in SAMARATE Varese, IT. FDA records list 57 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
57
PMA records
0
Recall records
6
Registered establishments
2

510(k) clearance history

Showing 50 of 57

FDA records hold 57 510(k) clearances for Quanta System Inc. between 2006 and 2025. The busiest year on record is 2017, with 7. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Quanta System Inc., by decision year
YearClearances
20061
20072
20083
20092
20102
20112
20121
20134
20142
20154
20164
20177
20186
20193
20205
20211
20222
20232
20242
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermGEXSubstantially Equivalent
K243588Single Use CO2 Laser Fiber (HAF005001)GEXSubstantially Equivalent
K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTGEXSubstantially Equivalent
K242251Litho 60; Litho 100; Litho 150GEXSubstantially Equivalent
K232236EchoGEXSubstantially Equivalent
K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VGEXSubstantially Equivalent
K220426Fiber Dust PROGEXSubstantially Equivalent
K211228RossoGEXSubstantially Equivalent
K210142Fiber DustGEXSubstantially Equivalent
K202503ChromeGEXSubstantially Equivalent
K202041Opera EvoGEXSubstantially Equivalent
K201455Litho 150, Cyber Ho 150GEXSubstantially Equivalent
K200234Surgical laser fibersGEXSubstantially Equivalent
K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60GEXSubstantially Equivalent
K192990Litho EvoGEXSubstantially Equivalent
K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermGEXSubstantially Equivalent
K192160EVO PlatformGEXSubstantially Equivalent
K182669Youlaser CO2GEXSubstantially Equivalent
K181632Venacure 1470 ProGEXSubstantially Equivalent
K180922Empower H100, Cyber Ho 100, Litho 100GEXSubstantially Equivalent
K180426Empower H35GEXSubstantially Equivalent
K180423Empower H65GEXSubstantially Equivalent
K180158Surgical Laser fibersGEXSubstantially Equivalent
K1730022940 nm Er:Yag Laser HandpieceGEXSubstantially Equivalent
K172376Discovery Pico, Discovery Pico PlusGEXSubstantially Equivalent
K172198585GEXSubstantially Equivalent
K172025Litho 60GEXSubstantially Equivalent
K171945Discovery Pico, Discovery Pico PlusGEXSubstantially Equivalent
K171711Thunder, Thunder VT, Thunder HRGEXSubstantially Equivalent
K170331Cyber HoGEXSubstantially Equivalent
K163222Discovery Pico FamilyGEXSubstantially Equivalent
K163009LithoGEXSubstantially Equivalent
K160368EVO platformGEXSubstantially Equivalent
K160513Quanta System Surgical Laser fibersGEXSubstantially Equivalent
K152714Quanta ForteGEXSubstantially Equivalent
K152012EVO platformGEXSubstantially Equivalent
K151629Guardian 1000GEXSubstantially Equivalent
K152220MH01GEXSubstantially Equivalent
K141101LITHOGEXSubstantially Equivalent
K141403LITHO DK30GEXSubstantially Equivalent
K131473(QUANTA SYSTEM) SURGICAL LASER FIBERSGEXSubstantially Equivalent
K131081CYBER TM FAMILYGEXSubstantially Equivalent
K130256MDK MULTI-APPLICATIONS PLATFORMGEXSubstantially Equivalent
K123573YOULASER CO2 LASERGEXSubstantially Equivalent
K123168Q-PLUS T+ IPL LASER SYSTEMGEXSubstantially Equivalent
K111592YOULASER CO2 LASER SYSTEMGEXSubstantially Equivalent
K103539QUANTA SYSTEM DUOLITEGEXSubstantially Equivalent
K102749QUANTA CYBER TM 150WGEXSubstantially Equivalent
K100558QUANTA DIODE LASER SYSTEMGEXSubstantially Equivalent
K091909LITHO LASER SYSTEMGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Quanta System Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30438612913043861291QUANTA SYSTEM INC.4747 NC Hwy 33 East, Suite F, Greenville, NC 27858 US2026No device listings on this registration
30043782993004378299QUANTA SYSTEM, S.P.A.VIA ACQUEDOTTO, 109, SAMARATE Varese 21017 IT2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1844-2021Quanta System Sterile Optical Laser Fiber, reusableProduct sterility is potentially compromised.Class IITerminated
Z-1843-2021Quanta System Sterile Optical Laser Fiber, single useProduct sterility is potentially compromised.Class IITerminated
Z-1842-2021Olympus Sterile Optical Laser Fiber, single use and reusableProduct sterility is potentially compromised.Class IITerminated
Z-0693-2013Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions.Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.Class IITerminated
Z-0692-2013Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acneQuanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.Class IITerminated
Z-0691-2013Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain