Olo is a device which emits laser radiation with a wavelength of 532 nm, which is delivered to the tissue through a transfer fiber and a handpiece or a scanner.

The Olo device electrical specifications are: 100-240V~, 50/60Hz, 600VA.

AI/ML Overview

The provided FDA 510(k) clearance letter for the El.En. S.p.A. Olo Laser Device does not contain information about acceptance criteria or a study proving that the device meets specific performance acceptance criteria for a diagnostic AI/ML device.

The document describes a laser surgical instrument, and its clearance is based on substantial equivalence to an existing predicate device (QuadroStar PRO). The "performance data" section explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" which refers to electrical safety, EMC, and software validation for the device's operational functions, not its diagnostic or an AI/ML component's performance.

Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or training set specifics from the provided text. The device described appears to be a physical medical device (laser) and not a software as a medical device (SaMD) or an AI/ML-powered diagnostic tool as indicated by the nature of the questions.

If the "Olo Laser Device" does incorporate AI/ML for diagnostic purposes, the provided FDA clearance letter is insufficient to detail how its performance was evaluated against specific diagnostic acceptance criteria. This type of information would typically be found in a separate Premarket Submission for AI/ML-enabled Medical Devices Guidance document or within the full submission details, which are not provided here.

Summary

FDA 510(k) Clearance Letter - Olo Laser Device

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.08.00
Silver Spring, MD 20993
www.fda.gov

August 6, 2025

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

Re: K251432
Trade/Device Name: Olo
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 7, 2025
Received: May 8, 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K251432 - Paolo Peruzzi Page 2

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 (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-

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K251432 - Paolo Peruzzi Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

TANISHA L. HITHE -S [Digitally signed by TANISHA L. HITHE -S Date: 2025.08.06 12:31:23 -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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FORM FDA 3881 (8/23) Page 1 of 1

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.

510(k) Number (if known): K251432

Device Name: Olo

Indications for Use (Describe):
Olo is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary

Olo

510(k) Number: K251432

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

Contact:
Paolo Peruzzi
Regulatory Affairs Manager & Official Correspondent
Phone: +39.055.8826807
E-mail: p.peruzzi@elen.it

Date Summary Prepared: August 4th, 2025

Device Trade Name: Olo

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 Device: QuadroStar PRO (K133297)

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Device Description:

Olo is a device which emits laser radiation with a wavelength of 532 nm, which is delivered to the tissue through a transfer fiber and a handpiece or a scanner.

The Olo device electrical specifications are: 100-240V~, 50/60Hz, 600VA.

Indications for Use:

Olo is intended for vaporisation and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.

Comparison with the Predicate Device:

The Olo device is as safe, as effective, and performs as well as the legally marketed predicate device QuadroStar PRO (K133297).

Device Trade Name	Proposed Device Olo	Predicate Device QuadroStar PRO (K133297)	Comment
Indications for Use	Olo is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues.	577 nm: intended for treatment of benign vascular and benign pigmented lesions. 532 nm: intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues.	Subset
Regulation number	21 CFR 878.4810	21 CFR 878.4810	Identical
Product Code	GEX	GEX	Identical
Device Type	Diode laser	Diode pumped solid state laser	Similar, differences do not affect safety and efficacy
Laser Wavelength	532 nm	532 nm or 577 nm (cannot be combined)	Subset
Principle of operation	Pulsed or CW optical excitation	Pulsed or CW optical excitation	Identical
Maximum Power	8 W	8 W (532 nm) 5 W (577 nm)	Identical
Pulse Duration	5 ms – 90 ms and CW	1 ms – 95 s and CW	Subset
Energy Range	Up to 1.9 J	Up to 1.9 J	Identical
Max Repetition Rate	10 Hz	20 Hz	Subset
Delivery	Transfer fiber	Transfer fiber	Identical

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Device Trade Name	Proposed Device Olo	Predicate Device QuadroStar PRO (K133297)	Comment
Spot diameters	Free hand handpiece: 1/1,5 mm Scanner: 1 mm	1 mm / optional: 0.5/1.5/2.8mm Scanner: 1 mm	Subset
Device Cooling	Internal water cooling	Internal air cooling	Similar, differences do not affect safety and efficacy
Power Supply	100 – 240 VAC, 50/60 Hz	100 – 240 VAC, 50/60 Hz	Identical

Clinical Performance Data:

None

Non-Clinical Performance Data:

Electrical safety and electromagnetic compatibility (EMC)

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

ANSI AAMI ES60601-1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 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: 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: Safety of laser products - Part 1: Equipment classification and requirements.

Software Validation and Verification Testing

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 devices and on the non-clinical performance data, we can conclude that Olo device is deemed to be substantially equivalent to the predicate device for the proposed indications for use.

Additional Information:

None.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.