Data / Medical devices / Malaysia / Harleigh (malaysia) Sdn. Bhd.
Harleigh (malaysia) Sdn. Bhd.: FDA-registered device maker in Johor Bahru, Malaysia, 6 510(k) clearances and 1 PMA approval
Harleigh (malaysia) Sdn. Bhd. is registered with the FDA (registration 3015430860) in Johor Bahru, Malaysia. It lists 3 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated April 12, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015430860
- Address
- No 4, Jalan Tahana,Tampoi Industrial Estate, Johor Bahru, Malaysia, 80350
- Owner or operator
- Harleigh (Malaysia) Sdn. Bhd. (10060965)
- Roles
- Repackager or relabeler
- First device listed
- July 22, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 12, 2021 | K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| December 11, 2018 | K182902 | Precision1 | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| October 25, 2017 | K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | LPL | Substantially Equivalent | Alcon Laboratories, Inc. | accessdata.fda.gov |
| January 29, 2014 | K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | LPL | Substantially Equivalent | Ciba Vision Corporation | 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 |
| January 24, 2008 | K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | LPL | Substantially Equivalent | Ciba Vision Corporation | 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 |
Compare with other makers
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lenses, Soft Contact, Extended Wear
- All makers of Lens, Contact, (Disposable)
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.