FDA product code MLY: Vapocoolant Device
MLY is the FDA product code for vapocoolant device. It is a Unclassified device, reviewed by the Physical Medicine panel. FDA has cleared 25 510(k) submissions under MLY, 5 in the last five years, from 13 different applicants. The average 510(k) review took 207 days (median 174); 161 days on average over the last three years. FDA has posted 7 recalls for MLY devices.
Classification
| Field | Value |
|---|---|
| Device name | Vapocoolant Device |
| Device class | Unclassified |
| Review panel | PM — Physical Medicine |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for MLY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 102 |
| 2018 | 1 | 233 |
| 2019 | 1 | 97 |
| 2020 | 3 | 105 |
| 2022 | 1 | 526 |
| 2024 | 1 | 164 |
| 2025 | 1 | 185 |
| 2026 | 2 | 135 |
Compare with all 510(k) review times · Search every MLY clearance
Top MLY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gebauer Co. | 7 | 2004-03-17 |
| Gebauer Company | 3 | 2026-08-27 |
| Vapocoolshot, Inc. | 3 | 2025-05-30 |
| Nuance Medical, LLC | 3 | 2024-02-12 |
| Cryosurgery, Inc. | 1 | 2026-09-05 |
8 more applicants have MLY clearances. See the full list in Caduvo.
Most recent MLY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261684 | Cryosurgery, Inc. | FreezeSpray TA | 2026-09-05 | 107 |
| K260870 | Gebauer Company | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | 2026-08-27 | 163 |
| K243654 | Vapocoolshot, Inc. | DentalJect | 2025-05-30 | 185 |
| K232674 | Nuance Medical, LLC | PainFreeze II | 2024-02-12 | 164 |
| K203661 | Cryoscience North America, Inc. | CRYO Arctic, CRYO Penguin | 2022-05-25 | 526 |
Recalls for MLY devices
7 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-09-03.
Frequently asked questions
What is FDA product code MLY?
MLY is the FDA product code for vapocoolant device. It is a Unclassified device, reviewed by the Physical Medicine panel.
What device class is MLY?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLY?
Across 25 cleared submissions the average was 207 days from receipt to decision (median 174).
Which companies have the most MLY clearances?
Gebauer Co. (7); Gebauer Company (3); Vapocoolshot, Inc. (3); Nuance Medical, LLC (3); Cryosurgery, Inc. (1).
Have MLY devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2008-09-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MLY
- Run a recall and safety report across every MLY manufacturer
- Watch product code MLY 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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