Deka Bluebeam

K243683 · El.En S.P.A. · GEX · Jun 12, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K243683
• Device Name: Deka Bluebeam
• Applicant: El.En S.P.A.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 12, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DEKA BlueBeam is a medical device intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue.

Device Story

Deka BlueBeam is a Class 4 diode laser system designed for surgical applications including incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue. The device operates at a 445nm wavelength with power output ranging from 0.5W to 10W. It supports continuous wave (CW), pulsed, and single-pulse modes. The system is air-cooled and utilizes optical fibers, with or without handpieces, to deliver laser energy to the target tissue. It includes a 520nm aiming beam. The device is intended for use by healthcare professionals in clinical settings. By delivering precise laser energy, the device enables controlled tissue interaction, facilitating surgical procedures and potentially improving patient outcomes through effective hemostasis and tissue management.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), particular requirements for surgical lasers (IEC 60601-2-22), and laser safety (IEC 60825-1).

Technological Characteristics

Diode laser, 445nm wavelength, 0.5-10W power. Class 4 laser. Air-cooled. Delivery via optical fibers with/without handpieces. Electrical: 100-230V~, 50/60Hz, 300VA. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for incision, excision, vaporization, ablation, hemostasis, and coagulation of body soft tissue in patients requiring surgical intervention.

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

• Wolf 445nm (K192272)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 12, 2025

El.En. S.p.A.
Paolo Peruzzi
Regulatory Affairs Manager
Via Baldanzese 17
Calenzano, Fl 50141
Italy

Re: K243683
Trade/Device Name: Deka Bluebeam
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX
Dated: May 15, 2025
Received: May 15, 2025

Dear Paolo Peruzzi:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243683 - Paolo Peruzzi
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

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K243683 - Paolo Peruzzi
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(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA L. HITHE -S
Digitally signed by
TANISHA L. HITHE -S
Date: 2025.06.12 14:26:38
-04'00"

Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K243683

Device Name
DEKA BLUEBEAM

Indications for Use (Describe)
The DEKA BlueBeam is a medical device intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K243683

DEKA BLUEBEAM

Submitter:

El.En. S.p.A.
Via Baldanzese, 17
50041 Calenzano (FI), Italy

Contact:

Paolo Peruzzi
Regulatory Affairs Manager & Official Correspondent
Phone: [phone]
E-mail: [e-mail]

Date Summary Prepared:

June 12th, 2025

Device Trade Name:

DEKA BLUEBEAM

Common Name:

Medical Laser

Regulation Number:

21 CFR 878.4810

Regulation Name:

Laser Surgical Instrument for use in General and Plastic and in Dermatology

Regulatory Class:

Class II

Product Code:

GEX

Predicate Devices:

Primary predicate: Wolf 445nm (K192272)

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Device Description:

The DEKA BLUEBEAM is a diode laser engineered to enhance performance in surgical applications. The DEKA BLUEBEAM electrical specifications are: 100-230V~, 50/60Hz, 300VA.

Indications for Use:

The DEKA BLUEBEAM is a medical device intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue.

Comparison with The Predicate Device:

The DEKA BLUEBEAM is as safe, as effective, and performs as well as the legally marketed predicate device (K192272):

| Device Trade Name | Proposed Device
DEKA BlueBeam | Predicate Device
Wolf 445nm
A.R.C. Laser GmbH
(K192272) | Comment |
| --- | --- | --- | --- |
| Indications for Use | Intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue | intended for use in incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue | Identical |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Product Code | GEX | GEX | Identical |
| Laser Type | Diode Laser | Diode Laser | Identical |
| Laser Power | From 0.5W to 10W | From 0.5W to 10W | Identical |
| Wavelength | 445nm | 445nm | Identical |
| Laser Class | 4 | 4 | Identical |
| Operation mode | Continuous Wave (CW), Pulsed mode (PW) or Single Pulse | Pulsed, Continuous Wave (CW) or Single Pulse (SP) | Identical |
| Pulse length / duration | 1 ms to 2 s | ≤ 4 Watt: 1 ms to 45 sec and CW > 4 Watt: 1 ms to 60 ms | Subset |

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| Device Trade Name | Proposed Device
DEKA BlueBeam | Predicate Device
Wolf 445nm
A.R.C. Laser GmbH
(K192272) | Comment |
| --- | --- | --- | --- |
| Pulse frequency | 0.25 to 500 Hz and Single Pulse | ≤ 4 Watt: 0.01 Hz to 500 Hz and SP
> 4 Watt: 0.02 Hz to 6.6 Hz and SP | Subset |
| Spot size | 0.27 to 0.6 mm | 0.3 to 0.6 mm | Similar |
| Aiming beam | 520 nm, 3.2mW | 532 nm, <5mW | Similar |
| Aiming beam power | 3.2 mW | ≤ 5 mW | Subset |
| Use in combination | optical fibers with or without handpieces | optical fibers with or without handpieces | Identical |
| Cooling | Air | Air | Identical |

Clinical Performance Data:
None

Non-Clinical Performance Data:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the DEKA BLUEBEAM device, according to the following standards:

- ANSI AAMI ES60601-1:2005/(R)2012 &amp; A1:2012 C1:2009/(R)2012 &amp; A2:2010/(R)2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 60601-2-22:2019 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1: 2014 - Safety of laser products - Part 1: Equipment classification and requirements.

Software Validation and Verification Testing

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Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".

**Conclusion:**

On the basis of the comparison with the predicate device and on the non-clinical performance data, we can conclude that DEKA BLUEBEAM is as safe, as effective, and performs as well as the legally marketed predicate device (K192272).

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