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news.Biolase Technology, a dental laser company, has received 510(k) clearance from the FDA allowing it to market a version of its Waterlase MD Laser System for use in dermatological applications as well as general and plastic surgery.
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New FDA-cleared indications for the Waterlase MD Derm device include incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing.
In addition, general surgical use of the device is now allowed for incision, excision, vaporization and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Jake St. Philip, CEO of Biolase, said: “Our singular operational focus is executing in the dental suite and building on the success of our hard- and soft-tissue dental laser franchise.”