Manufacturer
Biolase, Inc.Epic Pro
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K163128
- Device name
- Epic Pro
- Company
- Biolase, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-11-08
- Decision date
- 2017-01-11
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Epic Pro with surgical laser operation (Automatic Power Control) used in contact or non-contact mode, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva); examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket). The Epic Pro with surgical laser operation, used in contact or non-contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue. The Epic Pro with dental laser operation is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva); examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, pulpotomy as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.
Intended Use
The Epic Pro with surgical laser operation (Automatic Power Control) used in contact or non-contact mode, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva); examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket). The Epic Pro with surgical laser operation, used in contact or non-contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue. The Epic Pro with dental laser operation is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva); examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, pulpotomy as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.
Device Description
Epic Pro diode laser system is a surgical device designed for a wide variety of surgical and oral soft tissue procedures and dental whitening. Epic Pro utilizes a solid state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via a flexible fiber connected at one end to the laser source and at the other end to the handpiece. Various types of single use disposable tips are designed and optimized for different applications. The device is activated by means of a wireless footswitch.
Summary parsed at:2026-06-01 05:59:14 UTC
Predicate devices
1—
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Not ingested
K163128 references 1 predicate/reference device
Cited as predicate
3Epic Pro 940
Epic 980
SkyPulse
3 submissions cite K163128 as a predicate
