Look, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Look, Inc.” (first 1987, latest 1994), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 74 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 | 0 | — |
| 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 |
|---|---|---|---|
| HMX | Cannula, Ophthalmic | 5 | 5 |
| GAL | Suture, Absorbable, Natural | 3 | 3 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 2 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 | 1 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 1 | 1 |
| HNQ | Hook, Ophthalmic | 1 | 1 |
Plus 4 more product codes.
Review panels
- General and Plastic Surgery (12)
- Ophthalmic (10)
- General Hospital (3)
Most recent Look, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943949 | POLYVIOLENE SURGICL SUTURE | GAT | 1994-11-10 | 100 |
| K933686 | LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE | GAQ | 1993-12-23 | 147 |
| K926586 | REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES | GAL | 1993-12-22 | 386 |
| K926588 | REVISED LABELING FOR POLYPROPYLENE SUTURE | GAW | 1993-12-17 | 381 |
| K926587 | REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) | GAR | 1993-12-17 | 381 |
| K926168 | SILK SUTURES-REVISED LABELING | GAR | 1993-12-17 | 381 |
| K926167 | POLYVIOLENE SUTURE-REVISED LABELING | GAT | 1993-12-17 | 381 |
| K913530 | LOOK VISCODISSECTOR | HQC | 1991-10-21 | 74 |
| K903029 | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE | GAR | 1990-10-25 | 107 |
| K903584 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES | GAW | 1990-10-11 | 64 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Look, 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.
- Look Style, S.R.L. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Look, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Look, Inc.” (first 1987, latest 1994), across 14 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Look, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Look, Inc. is 74 days.
Which FDA product codes appear under Look, Inc.?
The most frequent FDA product codes under this applicant name are HMX (Cannula, Ophthalmic, 5); GAL (Suture, Absorbable, Natural, 3); GAR (Suture, Nonabsorbable, Synthetic, Polyamide, 3).
Next steps
- See all 25 Look, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HMX, Look, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.