K2 MOBILE

Hulaser, Inc.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K200693
Device name
K2 MOBILE
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-03-16
Decision date
2020-11-19
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingAcne treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

K2 mobile laser is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: Endodontic procedures: Pulpotomy, Root canal therapy; Periodontal procedures: Sulcular debridement; Implant procedures: Implant recovery; Surgery procedures: Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy. 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: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty. Others procedures: Gingival troughing, Hemostasis and coagulation, Leukoplakia, Treatment of aphthous-ulcer canker sores and herpetic lesions, Laser Assisted whitening, Topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. Laser Periodontal Indications: Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including: probe depth, attachment loss and tooth mobility), Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium. Tooth Whitening Indications: Laser Assisted whitening/bleaching of teeth. Light activation for bleaching materials for teeth whitening. Pain Indications: Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa.

Intended Use

K2 mobile laser is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: Endodontic procedures: Pulpotomy, Root canal therapy; Periodontal procedures: Sulcular debridement; Implant procedures: Implant recovery; Surgery procedures: Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy; 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 gingival and the following specific indications: Exposure of Unerupted teeth, Fibroma removal, Frenectomy, Gingival Troughing for crown impressions, Gingivectomy, Gingivoplasty, Hemostasis and coagulation, Gingival incision and excision hemostasis, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Oral papillectomies, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Gingival bleeding index, Excisional and incisional biopsies; Others procedures: Gingival troughing, Hemostasis and coagulation, Treatment of aphthous-ulcer canker sores and herpetic lesions.

Device Description

The iLaseTM dental soft tissue laser is a surgical device designed for a wide variety of dental soft tissue procedures and laser periodontal procedures. The laser output power range of the subject device is 0 to 6.0W. The maximum output power is 3.5W on CW mode and the maximum peak power is 6.0W on pulsed mode. The device uses an internal rechargeable lithium-ion battery (DC 3.7V, 1700mA).

Summary parsed at:2026-06-01 05:47:56 UTC

Predicate devices

2

K200693 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K200693 as a predicate