Data / Medical devices / Italy / General Trading & Services S.R.L.
General Trading & Services S.R.L.: FDA-registered device maker in Mascalucia (Ct) Catania, Italy, 16 510(k) clearances and 4 PMA approvals
General Trading & Services S.R.L. is registered with the FDA (registration 3012167421) in Mascalucia (Ct) Catania, Italy. It lists 5 device types. The FDA files 16 510(k) clearances and 4 PMA approvals under its listings, the newest dated November 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012167421
- Address
- Via Roma, 167, Mascalucia (Ct) Catania, Italy, 95030
- Owner or operator
- General Trading & Services S.R.L. (10050217)
- Roles
- Exporter to the US
- First device listed
- October 21, 2015
- Registered through
- 2026
- Brand names listed
- ACUVUE (senofilcon A) Soft Contact Lens Multifocal, ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC, ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A), ALEXANDER MCQUEEN, BALENCIAGA, BOTTEGA VENETA, BOUCHERON, BRIONI and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Frame, Spectacle | HQZ | 1 | Exporter to the US | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Exporter to the US | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Exporter to the US | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 29, 2021 | K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| March 17, 2020 | K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| January 18, 2019 | K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| December 11, 2018 | K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| May 30, 2013 | K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| February 21, 2013 | K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| June 5, 2012 | K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| March 30, 2012 | K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | LPL | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| January 5, 2010 | K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| November 1, 2006 | K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| June 22, 2006 | K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | MVN | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| May 27, 2005 | K050065 | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES | MVN | Substantially Equivalent | Ciba Vision Corporation | accessdata.fda.gov |
| October 28, 2004 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| February 26, 2002 | K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | LPL | Substantially Equivalent | Vistakon | accessdata.fda.gov |
| April 3, 1997 | K970095 | PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS | LPL | Substantially Equivalent | Biocompatibles Eyewear, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 30, 2018 | P170035 | Bausch + Lomb Ultra (samfilcon A) Contact Lenses | LPM | 18 | September 14, 2026 | accessdata.fda.gov |
| November 19, 2008 | P080011 | BIOFINITY (COMFILCON A) | LPM | 201 | September 2, 2026 | accessdata.fda.gov |
| December 20, 2005 | P040045 | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | LPM | 143 | October 16, 2026 | accessdata.fda.gov |
| February 5, 1999 | P980006 | PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR | LPM | 35 | March 17, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lenses, Soft Contact, Extended Wear
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Frame, Spectacle
Updated September 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.