Photon, Photon Plus

Zolar Technology & Mfg Co., Inc.

Country / region:Canada (CA)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K162114
Device name
Photon, Photon Plus
Country / region
Canada(CA)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-07-29
Decision date
2016-12-12
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Photon Series of Dental Diode Lasers are 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: 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 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 * Treatment of aphthous ulcer canker sores and herpetic. * Vestibuloplasty 2. 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. 3. TOOTH WHITENING INDICATIONS: * Laser Assisted whitening/bleaching of teeth. * Light activation for bleaching materials for teeth whitening. 4. 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, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Intended Use

The Photon Series of Dental Diode Lasers are 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: 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 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, Treatment of aphthous ulcer canker sores and herpetic, Vestibuloplasty. 2. 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. 3. TOOTH WHITENING INDICATIONS: Laser Assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth whitening. 4. 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, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Device Description

The Zolar Technology & MFG Co. Inc. Soft Tissue Dental Laser PHOTON/PHOTON PLUS uses a solid state diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to the hand piece that emits the energy to the target site. A visible light (aiming beam) is emitted at the same time to visually assist in identifying the specific treatment location. The Photon/Photon Plus Laser Systems are comprised of a base console, a detachable delivery system, tips and a wireless footswitch. The Photon/Photon Plus laser is intended to be used by dentists for a variety of oral soft tissue procedures.

Summary parsed at:2026-06-01 06:06:51 UTC

Predicate devices

3

K162114 references 3 predicate/reference devices

Cited as predicate

1

1 submission cite K162114 as a predicate