Data / Medical devices / Hong Kong / Bold Vision Group Limited
Bold Vision Group Limited: FDA-registered device maker in Hong Kong, Hong Kong, 11 510(k) clearances and 3 PMA approvals
Bold Vision Group Limited is registered with the FDA (registration 3012546757) in Hong Kong, Hong Kong. It lists 3 device types. The FDA files 11 510(k) clearances and 3 PMA approvals under its listings, the newest dated December 11, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012546757
- Address
- Room 1303, 13/F, Multifield Commercial Centre 426 Shanghai Street, Mongkok, Hong Kong, Hong Kong, 00000
- Owner or operator
- Bold Vision Group Limited (10052103)
- Roles
- Exporter to the US
- First device listed
- June 14, 2016
- Registered through
- 2026
- Brand names listed
- BIOFINITY (COMFILCON A) SOFT CONTACT LENS, BioTrue 1 Day Sphere, PROCLEAR 1 DAY 90 PACK, VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY), VISTAKON (SENOFILCON A) SOFT CONTACT LENS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| November 30, 2018 | K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| March 28, 2016 | K160212 | ACUVUE (senofilcon C) Soft Contact Lens | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| December 20, 2013 | K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| September 11, 2013 | K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | LPL | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| May 30, 2013 | K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| June 5, 2012 | K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | 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 |
| December 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | 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 |
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 |
|---|---|---|---|---|---|---|
| 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 Lenses, Soft Contact, Extended Wear
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
Updated September 2, 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.