Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The indications for use of the subject device are given below. 1. Dental soft tissue indications Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - fibroma removal - frenectomy - frenotomy - gingival troughing for crown impressions - gingivectomy - gingivoplasty - hemostasis and coagulation - implant recovery - incision and drainage of abscess - operculectomy - pulpotomy - soft tissue crown lengthening - treatment of herpetic and aphthous ulcers of the oral mucosa. 2. Laser periodontal procedures - laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket - sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.) 3. Whitening - light activation for bleaching materials for teeth whitening - laser-assisted whitening/bleach of teeth 4. Pain Relief - topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
The indications for use of the subject device are given below. 1. Dental soft tissue indications Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - fibroma removal - frenectomy - frenotomy - gingival troughing for crown impressions - gingivectomy - gingivoplasty - hemostasis and coagulation - implant recovery - incision and drainage of abscess - operculectomy - pulpotomy - soft tissue crown lengthening - treatment of herpetic and aphthous ulcers of the oral mucosa. 2. Laser periodontal procedures - laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket - sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.) 3. Whitening - light activation for bleaching materials for teeth whitening - laser-assisted whitening/bleach of teeth 4. Pain Relief - topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle
The SOLASE dental diode laser is a surgical and therapeutic device produced by Lazon Medical Laser Co., Ltd., designed for dental soft tissue indications, laser periodontal procedures, as well as teeth whitening and pain relief. It cannot be used for oral hard tissue. The SOLASE laser uses a laser diode as the beam source to radiate invisible infrared light, which is delivered to the operating area by optical fiber. It can generate a short laser pulse up to 10µs of interval. The SOLASE laser provides two different models with two different wavelengths - 808nm and 976nm, to meet customers' various requirements. The SOLASE laser is a Class 4 laser product which may cause injuries in improper handling. Therefore, it MUST be operated only by trained and qualified personnel.
Summary parsed at:2026-06-01 05:57:27 UTC
