REVOLIX AND REVOLIX JR

K051167 · Allmed Systems, Inc. · GEX · Jun 1, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051167
• Device Name: REVOLIX AND REVOLIX JR
• Applicant: Allmed Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RevoLix and RevoLix Jr laser systems and its fiber optic delivery system are intended for use in surgical procedures and endoscopic and endoscopic intended for used in surgical procedures and experience coagulation and hemostasis of soft including excision, resection, ablation, vaporization, valuation, varian and tissue in use in medical specialites inoldung: Orelegy, Central Surgery, General Surgery.and Arthroscopy

Device Story

RevoLix and RevoLix Jr are 2.01-micron diode-pumped solid-state surgical laser systems. The device consists of a laser console with an internal computer control panel, display, footswitch, and silica fiber optic delivery system. The distal tip is guided by a handpiece or endoscopic/laparoscopic instrument. The laser energy is used for ablation, coagulation, dissection, and resection of soft tissue in various surgical settings, including OR and endoscopic suites. Operated by physicians, the laser provides precise tissue interaction for procedures across multiple specialties. The output allows surgeons to perform minimally invasive or open surgeries with controlled hemostasis, potentially reducing patient trauma and recovery time compared to traditional methods.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

2.01-micron diode-pumped solid-state laser system. Components include laser console, internal computer control, display, footswitch, and silica fiber optic delivery system. Designed for open, laparoscopic, and endoscopic applications. Class II device.

Indications for Use

Indicated for open, laparoscopic, and endoscopic surgical procedures requiring incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft, mucosal, fatty, and cartilaginous tissue. Specialties include Urology (e.g., BPH, tumors, strictures), Gastroenterology (e.g., polyps, ulcers, calculi), Thoracic/Pulmonary (e.g., airway obstructions), Gynecology (e.g., fibroids, polyps), ENT (e.g., sinus surgery, tonsillectomy), Dermatology/Plastic Surgery (e.g., carcinomas, warts), General Surgery (e.g., cholecystectomy, mastectomy, appendectomy), and Arthroscopy/Orthopedic surgery (e.g., meniscectomy, discectomy, foraminoplasty). Contraindicated for use in the spine, except for specific percutaneous laser disc decompression/discectomy and foraminoplasty procedures.

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

• Lumenis/Coherent Medical - VersaPulse Ho:YAG Trimedyne Omnipulse Max 80 watt

Submission Summary (Full Text)

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JUN 1 - 2005

K051167 1/5

# Attachment V

# 510(k) Summary

# 1.General Information

AllMed Systems Inc. Submitter: 9232 Klemetson Drive Pleasanton CA 94588

> 925-468-0433 Phone:

925-399-5984 Fax

Peter Allen Contact Person

4" May 2005 Date Prepared

# 2. Names

| Device Name | Revolix Family of Laser Systems including the RevoLix<br>and RevoLix Jr |
|---------------------|-------------------------------------------------------------------------|
| Common Name | 2.01micron Laser System |
| Classification Name | Laser Surgical Instrument and accessories |

# 3. Predicate Device

Lumenis/Coherent Medical - VersaPulse Ho:YAG Trimedyne Omnipulse Max 80 watt

# 4. Product Description

The RevoLix and RevoLix Jr are diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The

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sme 7 2/5

laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument.

It consists of:

Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

# 5. Indications for Use

#### Arthroscopy

Arthroscopy/orthodepic surgery (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including

Meniscectomy Plica removal Ligament and Tendon release Contouring and sculpting of articular surfaces Debridement of inflamed synovial tissue (synovectomy) Loose body debridement Chondromalacia and tears Lateral retinecular release Capsulectomy in the knee Chondroplasty in the knee

Disectomy including

Percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine; open and arthroscopic spine procedures: foraminotomy

### Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP) Laser Resection of the Prostrate (HoLRP) Laser Enuculeation of the Prostate (HoLEP) Laser Ablation of the Prostate (HoLAP) Condylomas

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# Lesions of external genitalia

# Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including:

Appendectomy Polyps Biopsv Gail Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

### Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

Laryngeal Lesions Airway obstructions including carcinoma Polyps and Granulomas Palliation of obstructing carcinomas of the tracheobronchial tree

### Gynecology

Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)

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KOS1167
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Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and or vessel coagulation

Soft tissue excision procedures such as excisional conization of the cervix

# ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:

- Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal Tonsillectomy Adenoidectomy
# Dermatology and Plastic Surgery

Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:

Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts

### General Surgery

Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

> Cholecystectomy Lysis of adhesion Appendectomy Biopsy Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy

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- Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsy
# 6. Rationale for Substantial Equivalence

The Revolix and RevoLix Jr laser system with fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are substantially equivalent to the Lumenis VersaPulse Laser

# 7. Conclusion

The Revolix and RevoLix Jr Laser System with fiber optic delivery devices were found to be substantially equivalent to similar currently marketed and predicate surgical laser systems and delivery devices.

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Image /page/5/Picture/1 description: The image is a seal for the Department of Health and Human Services (HHS). The seal features an eagle-like symbol with three stylized lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 - 2005

Mr. Peter N. Allen President AllMed Systems Incorporated 9232 Klemetson Drive Pleasanton, California 94588

Re: K051167

Trade/Device Name: RevoLix and RevoLix Jr 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: May 4, 2005 Received: May 5, 2005

Dear Mr. Allen:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roved above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfor to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Peter N. Allen

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter with and hyour your finding of substantial equivalence of your device to a legally marketed 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 11 you usen's ffice of Compliance 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 micronal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

R.R.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: k051167

RevoLix and RevoLix Jr Device Name:

Indications For Use:

The Revolix and RevoLix Jr laser systems and its fiber optic delivery system are The Revolix and Revolix of laser Systems and endoscopic and endoscopic intended for used in surgical procedures and experience coagulation and hemostasis of soft including excision, resection, abiation, raponiation, valuation, varian and tissue in use in medical specialites inoldung: Orelegy, Central Surgery, General Surgery.and Arthroscopy

Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Urethrai Strictures

Bladder Neck Incisions (BNI)

Bladder Neck molono (DRI)
Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors.

Ablation of Benign Prostatic Hypertrophy (BHP),

Transurethral incision of the prostate (TUIP)

Laser Resection of the Prostrate (HoLRP)

Laser Enuculeation of the Prostate (HoLEP)

Laser Ablation of the Prostate (HoLAP)

Condylomas

Lesions of external genitalia

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, Open and endooooplo gagulation and hemostasis ) including:

Appendectomy Polyps Biopsy Gall Bladder calculi

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)

of CDRH Office of Device Evaluation (ODF)Concurrence of CDRH, Office of Device Evaluation (ODE)

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#### Kaf 1147 510(k) Number:

RevoLix and RevoLix Jr Device Name:

Indications For Use:

Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, excision, Open und ondeooople workization, coagulation and hemostasis) of soft tissue

Laryngeal Lesions Airway obstructions including carcinoma Polvps and Granulomas r offpo and Grandising carcinomas of the tracheobronchial tree

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carana. Page 2 of 5 12 8 239 11 11

Ka51167

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| 510(k) Number: | ~051167<br>ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

RevoLix and RevoLix Jr Device Name:

Indications For Use:

# Gynecology

Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)

> Intra-uterine treatment of submucous fibroids, benign endometrial polyps, mira uterine septum by incision, excision, ablation and or vessel coagulation Coagulation
> Soft tissue excision procedures such as excisional conization of the cervix

#### ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, Endostoplo enabliation and hemostasis of soft tissue) including:

- Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the orai, nasal, glossal, pharyngeal and laryngeal Tonsillectomy Adenoidectomy
# Dermatology and Plastic Surgery

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
| Page 3 of 5 |

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510(k) Number:

RevoLix and RevoLix Jr Device Name:

Indications For Use:

Incision, excision, resection, ablation, vaporization, coagulation and hemostasis melsion, exolon, recosment rtilaginous tissue, in therapeutic plastic, of soft, maoooal, fax) and aesthetic surgical procedures including:

Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags ﮨﮯ Plantar warts

### General Surgery

Open laparoscopic and endoscopic surgery (incision, excision, resection, Open raparooooooooon, coagulation and hemostasis) including:

> Cholecystectomy Lysis of adhesion Appendectomy Biopsv Skin incision Tissue dissection Excision of external tumors and lesions Excision of external carection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

Recorative

Devices

| Page 4 of 5 |
|-------------|
|-------------|

K051167

AND/OR

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#### Ko)1167 510(k) Number:

RevoLix and RevoLix Jr Device Name:

Indications For Use:

Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsy

### Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)

- Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including
- Surgery Including
Percutaneous Laser Disc Decompression/Discectomy Foraminoplasty
- Foraminoplasty
Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.

ズ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

(Urision Sign-Ori) libriston of Genoril. Reviewative cial Neurological Devices

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