FDA product code LYL: Accessories, Solution, Ultrasonic Cleaners For Lenses
LYL is the FDA product code for accessories, solution, ultrasonic cleaners for lenses. It is a Class II device, regulated under 21 CFR 886.5928 and reviewed by the Ophthalmic panel. FDA has cleared 22 510(k) submissions under LYL, 1 in the last five years, from 20 different applicants. The average 510(k) review took 167 days (median 146). 1 PMA application cites this product code. FDA has posted 14 recalls for LYL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Device class | Class II |
| Regulation | 21 CFR 886.5928 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LYL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 57 |
| 2022 | 1 | 255 |
Compare with all 510(k) review times · Search every LYL clearance
Top LYL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lens Comfort, Inc. | 2 | 1998-03-02 |
| Eaton Medical Corp. | 2 | 1992-08-25 |
| Suzhou 3N Biological Technology Co., Ltd. | 1 | 2022-01-13 |
| Vuesonic, LLC | 1 | 2021-04-01 |
| Bausch & Lomb, Inc. | 1 | 2009-11-18 |
15 more applicants have LYL clearances. See the full list in Caduvo.
Most recent LYL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211361 | Suzhou 3N Biological Technology Co., Ltd. | 3N Contact Lenses Adjunct Cleaner | 2022-01-13 | 255 |
| K210300 | Vuesonic, LLC | VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System | 2021-04-01 | 57 |
| K083757 | Bausch & Lomb, Inc. | BPZ02 MULTIPURPOSE SOLUTION | 2009-11-18 | 336 |
| K021699 | Autolens, Inc. | AUTOLENS CLEANING AND DISINFECTING UNIT | 2002-12-16 | 208 |
| K022687 | Ciba Vision Corporation | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | 2002-11-19 | 98 |
Recalls for LYL devices
14 product recalls in 8 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-04.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code LYL?
LYL is the FDA product code for accessories, solution, ultrasonic cleaners for lenses. It is a Class II device, regulated under 21 CFR 886.5928 and reviewed by the Ophthalmic panel.
What device class is LYL?
Class II, regulation 21 CFR 886.5928. Typical premarket route: 510(k).
How long does a 510(k) take for product code LYL?
Across 22 cleared submissions the average was 167 days from receipt to decision (median 146).
Which companies have the most LYL clearances?
Lens Comfort, Inc. (2); Eaton Medical Corp. (2); Suzhou 3N Biological Technology Co., Ltd. (1); Vuesonic, LLC (1); Bausch & Lomb, Inc. (1).
Have LYL devices been recalled?
Yes: 14 product recalls across 8 recall events; the most recent began 2023-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code LYL
- Run a recall and safety report across every LYL manufacturer
- Watch product code LYL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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