Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II

K043613 · Quantel Medical · HQF · Mar 24, 2005 · Ophthalmic

Device Facts

• Record ID: K043613
• Device Name: Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
• Applicant: Quantel Medical
• Product Code: HQF · Ophthalmic
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Optimis II Q-Switched Nd:YAG Photodisruptor is intended for posterior capsulotomy.

Device Story

Quantel Optimis II Q-Switched Nd:YAG Photodisruptor is an ophthalmic laser surgical instrument. Device utilizes Nd:YAG laser operating at nano-second pulse rate to perform photodisruption. Laser energy is delivered to treatment site via integrated slit lamp. Operated by ophthalmologists in clinical settings. Output is focused laser energy used for posterior capsulotomy. Device benefits patients by providing non-invasive surgical treatment for posterior capsule opacification.

Clinical Evidence

No clinical data; substantial equivalence established via comparison of indications and specifications.

Technological Characteristics

Nd:YAG laser; nano-second pulse rate; slit lamp delivery system; ophthalmic laser (21 CFR 886.4390).

Indications for Use

Indicated for posterior capsulotomy in patients requiring laser treatment of the posterior capsule.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

• AURA (Coherent) (K992824)
• LQP4106 ERA (Laserex) (K992824)
• 3000 LE (Alcon) (K992824)
• LQ2106 (Laserex) (K992824)
• LQP3106 (Laserex) (K992824)
• 3000LX (Laserex) (K992824)

Submission Summary (Full Text)

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K043613, p. 1 of 2

## 510(k) SUMMARY

This 510(k) summary of safety and effectiveness for the modification in the Indications for Use for the Quantel Optimis II Q-Switched Nd: Y AG Photodisruptor is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Quantel Medical | MAR 2 4 2005 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Address: | QUANTEL MEDICAL<br>89, Boulevard Etienne<br>CLEMENTEL<br>63100 Clermont-Ferrand<br>FRANCE | |
| Contact Person: | Mr. Jean Abascal<br>Regulatory Affairs Manager<br>([phone]<br>([phone] | |
| Preparation Date:<br>(of the Summary) | December 2004 | |
| Device Name: | Quantel Optimis II Q-Switched Nd:YAG Photodisruptor | |
| Common Name: | Ophthalmic Laser Photodisruptor<br>Laser Surgical Instrument | |
| Classification: | Ophthalmic laser (21 CFR 886.4390) | |
| Product Code: | HQF; Panel: 86 | |
| Predicate devices: | AURA™ (Coherent), LQP4106 ERA (Laserex), 3000 LE (Alcon), LQ2106 (Laserex), LQP3106 (Laserex) and 3000LX (Laserex) - see K992824. | |
| Device description: | The Quantel Optimis II Q-Switched Nd:YAG Photodisruptor in a Nd:YAG laser which operates at a nano-second pulse rate. The laser energy is delivered to the treatment site using a provided Optimis II slit lamp. | |
| Indications: | The Quantel Optimis II Q-Switched Nd:YAG Photodisruptor is indicated for posterior capsulotomy. | |
| Performance Data: | None required - comparison of indications and specifications/characteristics established the substantial equivalence of the Optimis II laser to predicates. | |

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K043613, p. 2 of 2

- CONCLUSION: Based on the information in this notification Quantel Medical concludes that the Optimis II Q-Switched Nd:YAG Photodisruptor is substantially equivalent to the cited legally marketed predicates (K992824).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 4 2005

Quantel Medical c/o Mr. Roger Barnes Regulatory Consultant 342 Sunset Bay Road Hot Springs, Arkansas 71913

Re: K043613

Trade/Device Name: Quantel Optimis II Q-Switched Nd: YAG Photodisruptor Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: December 30, 2004 Received: December 30, 2004

Dear Mr. Barnes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 commerce prior 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 (IPMA). 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 fisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth 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. Roger Barnes

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier wifi and w you to organ inding 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 IT you ucare specific acrite in 1 2 - 1 1 5. Also, please note the regulation entitled, Colliaci the Office of Comphalise at (21 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/industry/support/index.html.

Sincerely vours,

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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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Quantel Optimis II Q-Switched Nd: YAG Photodisruptor_____________________________________________________________________________________________________________

Indications for Use Statement:

The Optimis II Q-Switched Nd:YAG Photodisruptor is intended for posterior capsulotomy.

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