Lutronic Corporation recalls Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device…
Reason for recall
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured with an Intelligent Cooling Device (ICD) to provide epidermal cooling during laser treatmentModel DermaV95 affected lots1.0608800291820200DV025A010DV025A011DV025A012DV025A013DV025A014DV025A015
+87 more
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
What the firm is doing
Firm began notifying customers on 8/6/26. Customers were instructed to discontinue use of previous parameters and utilize the new revised clinical cryogen parameters. Updated cryogen parameters were provided with the letter. If you have questions or need assistance, please contact Clinical Support at 844-365-5060 or via email at clinical@cynosurelutronic.com.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Canada and European Union.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3110-2026
- FDA 510(k) clearance · K203788The device's official FDA premarket clearance record
- FDA device classification · GEXOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4810The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Lutronic CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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