ADEPT ULTRALITE 532 LASER

K042496 · Adept Medical Concepts · GEX · Nov 2, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042496
• Device Name: ADEPT ULTRALITE 532 LASER
• Applicant: Adept Medical Concepts
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ADEPT ULTRALITE 532 LASER is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue. Examples include: Telangiectasia Spider Naevi Angioma Hemangioma Leg veins (small, superficial - see above) Epidermal Naevi Lentigines (solar and senile) Verrucae Vulgares (Warts) Cherry Angioma Port Wine Stain

Device Story

Adept UltraLite 532 Laser is a diode-pumped solid-state (DPSS) frequency-doubled laser emitting coherent light at 532 nm. Device delivers laser energy via quartz fiber and handpiece to target vascular and pigmented lesions in soft tissue. Operates in continuous wave (CW) or pulsed modes (10 ms pulse width; 0.3-100 Hz repetition rate; 1-5 W power). Used by clinicians in dermatology or plastic surgery settings for vaporization and photocoagulation. Output allows precise tissue interaction to treat specific dermatological conditions, potentially improving patient cosmetic outcomes and lesion clearance.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on performance data comparisons of specifications and characteristics.

Technological Characteristics

Diode-pumped solid-state (DPSS) frequency-doubled laser; 532 nm wavelength; 1-5 W power range; 10 ms pulse width; 0.3-100 Hz repetition rate. Delivery system consists of a quartz fiber with a handpiece. Operates in CW or pulsed modes.

Indications for Use

Indicated for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue, including telangiectasia, spider naevi, angioma, hemangioma, small superficial leg veins, epidermal naevi, solar/senile lentigines, verrucae vulgares (warts), cherry angioma, and port wine stains.

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

• BeautyStar 532 Laser (K021975)
• DioLite 532

Submission Summary (Full Text)

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K042496/A'
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ATTACHMENT 5

#### 510(k) SUMMARY

This 510(k) summary of safety and effectiveness for the Adept UltraLite 532 Laser 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.

- Adept Medical Concepts, Inc. Applicant: 29816 Avenue De Las Banderas Address: Rancho Santa Margarita, CA 92688 Mr. Jerry McFarland Contact person: President [e-mail] Telephone: [phone] (fax) Preparation Date: August 2004 (of the Summary) Adept UltraLite 532 Laser Device Name: Surgical laser Common Name: Laser surgical instrument for use in general and plastic surgery and Classification: dermatology Class II medical device; (21 CFR 878.4810). Product Code: GEX Panel: 79 The Laser System BeautyStar 532 Laser (K021975). Predicate device: Device description: The Adept UltraLite 532 Laser is a diode laser which emits coherent light at 532 nm. Indications for Use: The ADEPT ULTRALITE 532 LASER is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue
Image /page/0/Picture/6 description: The image shows the word "DRAFT" in a bold, sans-serif font. The letters are heavily textured, giving them a distressed or weathered appearance. The word is slightly angled from left to right.

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K042496
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Examples include:

Telangiectasia Spider Naevi Angioma Hemangioma Leg veins (small, superficial) Epidermal Naevi Lentigines (solar and senile) Verrucae Vulgares (Warts) Cherry Angioma Port Wine Stain

- The claim of substantial equivalence is based on Performance Data: None required. comparisons of specifications/characteristics and intended uses of the UltraLite 532 and the claimed predicates, i.e., the BeautyStar 532 and DioLite 532 lasers.
- Conclusion: Based on the information in the notification Adept Medical Concepts, Inc., believes that the Adept UltraLite 532 Laser as described in this notification is substantially equivalent to the claimed predicates for the indications for use as listed above.

rev. 10/2004

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# Name of Manufacturer: Lasering, SRL, Modena, Italy; marketed by Adept Medical Concepts, Inc.

Laser Model Name and Number: Adept Ultralight 532

Laser Type: (Circle all that apply) Laser Typt. " (Chele an that appr, ) " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other ______________________________________________________________________________________________________________________

Indications in this application: Vaporization and photocoagulation of vascular and Tigmented lesions in soft tissue. Examples include: Telangiectasia, Spider Naevi, Premented forms in betweens (small, superficial-see above), Epidermal Naevi, Lentigines (solar and senile), Verrucae Vulgares (Warts), Cherry Angioma, Port Wine Stain.

### FDA Document Control Number: K042496

FDA Product Code: 79 GEX, Class II

Reviewer Computer Initials: ABC

Date of Clearance Letter: 10/22/04

Basis of Approval: (Circle all that apply) Predicate Devices (PD), Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other____________________________________________________________________________________________________________

Description of Laser: The Ultralight 532 is a diode pumped solid state frequency doubled laser appliance.

Operation Modes: (Circle all that apply) CW, Pulsed, Q-Switched, Mode Locked, Contact, Free Beam, Other_or continuous

Wavelength in Nanometers: 532

Power/Energy Range (Watts): 1-5 W

Pulse Width: 10 ms

Repetition Rate: 0.3-100 Hz

Delivery System: Quartz Fiber with Hand piece

Comments:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a stylized human figure with outstretched arms. The symbol is composed of three curved lines that suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2004

Mr. Jerry McFarland President Adept Medical Concepts, Inc. 29816 Avenue De Las Banderas Rancho Santa Margarita, California 92688

Re: K042496

Trade/Device Name: ADEPT ULTRALITE 532 LASER 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: September 10, 2004 Received: September 17, 2004

Dear Mr. McFarland:

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 forchenous a over and harsure) 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 (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 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. Jerry McFarland

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premium to modicate 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 contact the Office 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 Manufacturers, 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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#### ATTACHMENT 2

## INDICATIONS FOR USE STATEMENT

13042496 510(k) Number (if known):

Device Name: ADEPT ULTRALITE 532 LASER

Indications for Use Statement:

The ADEPT ULTRALITE 532 LASER is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.

Examples include:

- Telangiectasia Spider Naevi Angioma Hemangioma Leg veins (small, superficial - see above) Epidermal Naevi Lentigines (solar and senile) Verrucae Vulgares (Warts) Cherry Angioma Port Wine Stain
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation

Prescription Use X
(Per 21 CFR 801.109)

*Miriam C. Provost* Over-The Counter Use
(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number_K 642496