VERSAWAVE DENTAL ER:YAG LASER SYSTEM

K041710 · Hoya Conbio · GEX · Aug 3, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041710
• Device Name: VERSAWAVE DENTAL ER:YAG LASER SYSTEM
• Applicant: Hoya Conbio
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The VersaWave Dental Er:YAG Laser System is intended for Hard Tissue General Indications: Class I, II, III, IV and V cavity preparation. Carries removal. Hard tissue surface roughening or etching. Enameloplasty, excavation of pits and fissures for placement of sealants. Root Canal Hard Tissue Indications: Tooth preparation to obtain access to root canal. Root canal preparation including enlargement. Root canal debridement and cleaning. Bone Surgical Indications: Cutting, shaving, contouring and resection of oral osseous tissues (bone). Osteotomy. Endodontic Surgery (Root Amputation) Indications: Flap preparation incision of soft tissue to prepare a flap and expose the bone. Cutting bone to prepare a window access to the apex (apices) of the root(s). Apicoectomy amputation of the root end. Root end preparation for retrofill amalgam or composite. Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex. Laser Periodontal Procedures: Full thickness flap. Partial thickness flap. Split thickness flap. Laser soft tissue curettage. Laser removal of diseased, infected, inflamed, and necrosed soft tissue within the periodontal pocket. Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium. Removal of granulation tissue from bony defects. Sulcular debridement. Osteoplasty and osseous recontouring. Ostectomy. Osseous crown lengthening. Soft Tissue Indications Including Pulpal Tissues: Incision, excision, vaporization, ablation, and coagulation of oral soft tissues, including: Excisional and incisional biopsies. Exposure of unerupted teeth. Fibroma removal. Flap preparation-incision of soft tissue to prepare a flap and expose the bone. Flap preparation-incision of soft tissue to prepare a flap and expose the unerupted teeth (hard and soft tissue impactions). Frenectomy and frenotomy. Gingival troughing for crown impressions. Gingivectomy. Gingivoplasty. Gingival incision and excision. Hemostasis and coagulation. Implant recovery. Incision and drainage of abscesses. Incision and drainage of periapical abscesses. Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery. Leukoplakia. Operculectomy. Oral papillectomies. Pulpotomy. Pulp extirpation. Pulpotomy as an adjunct to root canal therapy. Reduction of gingival hypertrophy. Removal of pathological tissues (i.e. cysts, neoplasm, abscess) and hyperplastic tissues (i.e. granulation tissue). Root canal debridement and cleaning. Soft tissue crown lengthening. Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplaty. *For use on adult and pediatric patients.

Device Story

VersaWave Dental Er:YAG Laser System is a medical laser for dental applications. Device uses Er:YAG laser energy to perform hard and soft tissue procedures, including cavity preparation, bone resection, and soft tissue ablation/coagulation. Operated by dental professionals in clinical settings. Laser energy interacts with target tissues to achieve cutting, vaporization, or hemostasis. Output is controlled by the clinician to facilitate surgical access, tissue removal, or therapeutic treatment. Benefits include precise tissue management and reduced need for traditional mechanical instruments. Device is used for both adult and pediatric patients.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Er:YAG laser surgical instrument. Operates as a powered laser system for hard and soft tissue dental applications. Class II device.

Indications for Use

Indicated for adult and pediatric patients requiring oral hard tissue procedures (cavity prep, caries removal, bone surgery, endodontic surgery), periodontal procedures (flap, curettage, debridement, osseous recontouring), and soft tissue procedures (incision, excision, ablation, coagulation, biopsy, frenectomy, pulpotomy).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• DELight Dental Er: YAG Laser System
• WaterLase, Millennium Dental Laser System
• Premier Centauri Dental Laser System

Submission Summary (Full Text)

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K041710 1/3

### 9. 510(k) Summary

## AUG - 3 2004

| Company: | HOYA ConBio (formerly Continuum Electro-Optics, Inc.)<br>47733 Fremont Blvd<br>Fremont, CA 94538<br>[phone] phone<br>[phone] fax |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jim Green<br>Vice President of Engineering |
| Device Trade Name: | VersaWave Dental Er:YAG Laser System |
| Common Name: | Medical Laser System |
| Classification Name:<br>Classification Code: | Instrument, surgical, powered, laser<br>79-GEX |
| Equivalent Device(s): | DELight Dental Er: YAG Laser System<br>WaterLase, Millennium Dental Laser System<br>Premier Centauri Dental Laser System |
| Intended Use: | The VersaWave Dental Er:YAG Laser System is intended for |

### Hard Tissue General Indications*

- Class I, II, III, IV and V cavity preparation .
- Carries removal .
- Hard tissue surface roughening or etching .
- Enameloplasty, excavation of pits and fissures for placement of sealants .

*For use on adult and pediatric patients

## Root Canal Hard Tissue Indications

- Tooth preparation to obtain access to root canal .
- Root canal preparation including enlargement .
- Root canal debridement and cleaning .

## Root Canal Hard Tissue Indications

- Tooth preparation to obtain access to root canal ●
- Root canal preparation including enlargement .
- Root canal debridement and cleaning .

### Bone Surgical Indications

- Cutting, shaving, contouring and resection of oral osseous tissues (bone) .
- . Osteotomy

## Endodontic Surgery (Root Amputation) Indications

- Flap preparation incision of soft tissue to prepare a flap and expose the bone .

{1}------------------------------------------------

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- Cutting bone to prepare a window access to the apex (apices) of the root(s). .
- Apicoectomy amputation of the root end. .
- Root end preparation for retrofill amalgam or composite .
- Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic . Removal of pathological nesues (rom around the apex. Note: Any tissue growth (i.e. tissues (1.6. grandiaren besions) must be submitted to a qualified laboratory for histopathological evaluation.

### Laser Periodontal Procedures

- Full thickness flap .
- Partial thickness flap .
- Split thickness flap .
- Laser soft tissue curettage .
- Laser son ubsed of our and of the . periodontal pocket
- perfouontal pother
Removal of highly inflamed edematous tissue affected by bacteria penetration of the . pocket lining and junctional epithelium
- Removal of granulation tissue from bony defects .
- Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue . in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- gingi rai otooming masti, master, many of bone to correct osseous defects and . create physiological osseous contours)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for . grafting, etc.)
- Osseous crown lengthening .

## Soft Tissue Indications Including Pulpal Tissues*

Incision, excision, vaporization, ablation, and coagulation of oral soft tissues, including:

- Excisional and incisional biopsies .
- Exposure of unerupted teeth .
- Fibroma removal .
- Flap preparation-incision of soft tissue to prepare a flap and expose the bone. .
- Flap preparation-incision of soft tissue to prepare a flap and expose the unerupted . teeth (hard and soft tissue impactions)
- Frenectomy and frenotomy .
- Gingival troughing for crown impressions .
- Gingivectomy .
- . Gingivoplasty
- Gingival incision and excision .
- Hemostasis and coagulation .
- Implant recovery ●
- Incision and drainage of abscesses .
- Incision and drainage of periapical abscesses .
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area . during apical surgery

{2}------------------------------------------------

$$<\mathcal{V} \not\rightarrow \mathcal{V} \not\rightarrow \mathcal{V} \mathcal{C} \equiv \mathcal{V} \mathcal{C}$$

- . Leukoplakia
- Operculectomy .
- Oral papillectomies .
- Pulpotomy .
- . Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy .
- Reduction of gingival hypertrophy .
- Removal of pathological tissues (i.e. cysts, neoplasm, abscess) and hyperplastic . tissues (i.e. granulation tissue). Note: any tissue growth (i.e., cyst, neoplasm or other tissues (f.c. grandration aboratory for histopathological evaluation.
- Root canal debridement and cleaning .
- Soft tissue crown lengthening .
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa .
- Vestibuloplaty .

*For use on adult and pediatric patients

The VersaWave Dental Er: YAG Laser System, the DELight Er: Comparison: Y AG Laser System, the WaterLase, Millennium Dental Laser System, and the Premier Centauri Dental Laser System are equivalent in operating parameters, physical characteristics, and intended uses.

| Nonclinical Performance<br>Data: | None |
|----------------------------------|------|
| Clinical Performance Data: | None |
| Additional Information: | None |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2004

Mr. Jim Green Vice President of Engineering Hoya ConBio 47733 Fremont Boulevard Fremont, California 94538

Re: K041710 K0+1710
Trade/Device Name: VersaWave Dental Er:YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 18, 2004 Received: June 29, 2004

Dear Mr. Green:

We have reviewed your Section 510(k) premarket notification of intent to market the devices indication we nave reviewed your bectorit 310(t) presidentially equivalent (for the indications
referenced above and have determined the device is substantially equivalent felerenced above and nave determined with marketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manner date of the Medical Device Amendments, or to commerce prior to May 20, 1776, the enaounce with the provisions of the Federal Food, Drug, devices that have been recalismed in accessfire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approva and Cosmetic Act (71ct) that Go not request of the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (300 a0070) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not nean Ficase oe advised that I DTT 3188aa.co brour device complies with other requirements of the Act that IDA has made a decormination administered by other Federal agencies. You must of ally I cut all the Act's requirements, including, but not limited to: registration and listing (21 Compry with an the Ace 3 requirements, one . enomantfacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable the electronic forth in the quality systems (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2 - Mr. Jim Green

This letter will allow you to begin marketing your device as described in your Section 510(k) This iction will and will and of substantial equivalence of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at no 101 ) at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 6. Indications for Use Statement

K041710 510(k) Number:

Device Name:

VersaWave Dental Er:YAG Laser System

Indications for Use:

### Hard Tissue

#### General Indications*

- Class I, II, III, IV and V cavity preparation .
- Carries removal .
- Hard tissue surface roughening or etching .
- Flard doods carrer and fissures for placement of sealants .

*For use on adult and pediatric patients

## Root Canal Hard Tissue Indications

- Tooth preparation to obtain access to root canal .
- Root canal preparation including enlargement .
- Root canal debridement and cleaning .

## Root Canal Hard Tissue Indications

- Tooth preparation to obtain access to root canal .
- Root canal preparation including enlargement .
- Root canal debridement and cleaning .

### Bone Surgical Indications

- Cutting, shaving, contouring and resection of oral osseous tissues (bone) .
- Osteotomy .

## Endodontic Surgery (Root Amputation) Indications

- offer Burger J (1000) is incision of soft tissue to prepare a flap and expose the bone .
- Cutting bone to prepare a window access to the apex (apices) of the root(s). .
- Apicoectomy amputation of the root end. .
- Root end preparation for retrofill amalgam or composite .
- Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic . tissues (i.e. granulation tissue) from around the apex. Note: Any tissue growth (i.e. trists, neoplasm, or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

### Laser Periodontal Procedures

- Full thickness flap .
- Partial thickness flap .
- Split thickness flap .
- Laser soft tissue curettage .

{6}------------------------------------------------

- Laser removal of diseased, infected, inflamed, and necrosed soft tissue within the . periodontal pocket
- periodomial pocket
Removal of highly inflamed edematous tissue affected by bacterna penetration of the . pocket lining and junctional epithelium
- Removal of granulation tissue from bony defects .
- Removal of granufation assub from Seny and features or necrosed soft tissue . Suicular debrident (removal of electional indices including gingival index.
in the periodontal pocket to improve clinical indices including gingival index. In the perfodomal pooker to maps.
- gifigival bleeding moce uspan, in
Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and . create physiological osseous contours)
- Ostectorysionogical 665008 between bony architecture, resection of bone for . grafting, etc.)
- Osseous crown lengthening .

## Soft Tissue Indications Including Pulpal Tissues*

Incision, excision, vaporization, ablation, and coagulation of oral soft tissues, including:

- Excisional and incisional biopsies .
- Exposure of unerupted teeth .
- Fibroma removal .
- Flap preparation-incision of soft tissue to prepare a flap and expose the bone. .
- I Tap preparation incision of soft tissue to prepare a flap and expose the unerupted . teeth (hard and soft tissue impactions)
- Frenectomy and frenotomy .
- Gingival troughing for crown impressions .
- Gingivectomy .
- Gingivoplasty .
- Gingival incision and excision .
- Hemostasis and coagulation ●
- Implant recovery ●
- Incision and drainage of abscesses ●
- Incision and drainage of periapical abscesses .
- Incision and Gramage of the post-extraction tooth sockets and the periapical area . during apical surgery
- Leukoplakia .
- Operculectomy .
- Oral papillectomies .
- Pulpotomy .
- Pulp extirpation .
- Pulpotomy as an adjunct to root canal therapy .
- Reduction of gingival hypertrophy .
- Recuenon of gingival tissues (i.e. cysts, neoplasm, abscess) and hyperplastic . tissues (i.e. granulation tissue). Note: any tissue growth (i.e., cyst, neoplasm or other tissues (I.C. grandhation assac). Trevel in the many for histopathological evaluation.
I sions) must be submitted to a qualified laboratory for histopathological evaluation.
- Root canal debridement and cleaning .
- Soft tissue crown lengthening .

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3/3

- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ●
- Vestibuloplaty .

*For use on adult and pediatric patients

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart D)

OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K041710 510(k) Number_