Alden Optical Labs., Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Alden Optical Labs., Inc.” (first 1997, latest 2013), plus 1 PMA decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 61 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 78 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 11 | 10 |
Review panels
- Ophthalmic (11)
Most recent Alden Optical Labs., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133079 | IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) | LPL | 2013-12-17 | 78 |
| K102557 | NOVAKONE SPHERICAL AND TORIC LENSES | LPL | 2011-04-26 | 231 |
| K091327 | ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES | LPL | 2010-06-25 | 416 |
| K052703 | ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL | LPL | 2005-11-10 | 43 |
| K042242 | ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES | LPL | 2004-09-15 | 27 |
| K983278 | OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) | LPL | 1998-11-25 | 69 |
| K983053 | ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) | LPL | 1998-10-21 | 50 |
| K981252 | OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) | LPL | 1998-06-23 | 78 |
| K980554 | ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) | LPL | 1998-04-07 | 53 |
| K973967 | AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) | LPL | 1997-12-08 | 52 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P820078 | PMA | AL-47 SOFT CONTACT LENS | 1984-01-30 |
Recalls
openFDA lists no recalls under a recalling firm named Alden Optical Labs., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alden Scientific, Inc. (2 510(k)s)
- Alden Products Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alden Optical Labs., Inc.?
FDA lists 10 510(k) clearances under the applicant name “Alden Optical Labs., Inc.” (first 1997, latest 2013), plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alden Optical Labs., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alden Optical Labs., Inc. is 61 days.
Which FDA product codes appear under Alden Optical Labs., Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 11).
Next steps
- See all 10 Alden Optical Labs., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Alden Optical Labs., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.