Data / Medical devices / Indonesia / PT. Ciba Vision Batam
PT. Ciba Vision Batam: FDA-registered device maker in BATAM ISLAND Riau, Indonesia, 6 510(k) clearances and 4 PMA approvals
PT. Ciba Vision Batam is registered with the FDA (registration 9681121) in BATAM ISLAND Riau, Indonesia. It lists 13 device types. The FDA files 6 510(k) clearances and 4 PMA approvals under its listings, the newest dated January 10, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9681121
- FEI number
- 3002807944
- Address
- JL BERINGIN LOT No. 204 BATAMINDO INDUSTRIAL PARK, MUKA KUNING, BATAM ISLAND Riau, Indonesia, 29433
- Owner or operator
- Alcon Laboratories, Inc. (1610287)
- Roles
- Manufacturer
- First device listed
- February 3, 1994
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | 1 | Manufacturer | accessdata.fda.gov |
| Cannula, Trocar, Ophthalmic | NGY | 1 | Manufacturer | accessdata.fda.gov |
| Extended Depth Of Focus Intraocular Lens | POE | 3 | Manufacturer | accessdata.fda.gov |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | 2 | Manufacturer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Manufacturer | accessdata.fda.gov |
| Laser, Ophthalmic | HQF | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Intraocular, Toric Optics | MJP | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Multifocal Intraocular | MFK | 3 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Manufacturer | accessdata.fda.gov |
| Photocoagulator And Accessories | HQB | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 10, 2024 | K233902 | Centurion Vision System (Active Sentry) (8065753057) | HQC | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| August 3, 2018 | K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| August 22, 2014 | K141065 | CONSTELLATION VISION SYSTEM | HQE | Substantially Equivalent | Alcon Research, Ltd. | accessdata.fda.gov |
| October 17, 2011 | K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA | HQB | Substantially Equivalent | Alcon Research, Ltd. | accessdata.fda.gov |
| November 12, 2010 | K101285 | CONSTELLATION VISION SYSTEM | HQC | Substantially Equivalent | Alcon Manufacturing, Ltd. | accessdata.fda.gov |
| November 5, 2007 | K062624 | NEXT GENERATION LASER | HQF | Substantially Equivalent | Alcon Laboratories | 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 |
|---|---|---|---|---|---|---|
| October 11, 2001 | P010019 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | LPM | 83 | May 29, 2026 | accessdata.fda.gov |
| December 22, 1994 | P930014 | ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES | HQL | 161 | July 8, 2026 | accessdata.fda.gov |
| January 31, 1990 | P880087 | KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7U | HQL | 30 | June 20, 2024 | accessdata.fda.gov |
| April 30, 1986 | P840060 | SM-1, CR-1, & GR-1 IOLS | HQL | 45 | June 20, 2024 | accessdata.fda.gov |
Compare with other makers
- All makers of Intraocular Lens
- All makers of Cannula, Ophthalmic
- All makers of Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
- All makers of Extended Depth Of Focus Intraocular Lens
- All makers of Lens, Multifocal Intraocular
- All makers of Lens, Intraocular, Toric Optics
Updated May 29, 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.