Boston PICO (Boston PICO)

K251981 · Boston Aesthetics, Inc. · GEX · Jan 30, 2026 · General, Plastic Surgery

Device Facts

• Record ID: K251981
• Device Name: Boston PICO (Boston PICO)
• Applicant: Boston Aesthetics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 30, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boston PICO is indicated for surgical and cosmetic use in dermatology department, general surgery department and plastic surgery department, details are as follows: 1064 nm wavelength: - Remove tattoos of all skin types (Fitzpatrick skin type I-VI) in the following colors: black, brown, green, blue and purple. - Treat benign pigmented skin lesions of Fitzpatrick I-IV types. 532 nm wavelength: - Remove tattoos of Fitzpatrick skin type I-III in the following colors: red, yellow and orange. - Treat benign pigmented skin lesions of Fitzpatrick I-IV types. Microbeam handpieces (1064nm and 532nm) are used for the treatment of wrinkles for skin types I-IV.

Device Story

Boston PICO is a multi-wavelength, solid-state pulsed laser system; delivers 1064nm and 532nm wavelengths at 250ps pulse duration. Operates by disrupting tattoo dye or pigment particles via photomechanical effect; fragmented particles surface and fade as skin renews. Used in dermatology, general, and plastic surgery departments; operated by physicians. System features co-linear beam paths for 1064nm/532nm output through a single articulated arm and interchangeable handpieces. Output parameters (wavelength, pulse duration, energy fluence) are controlled by the user to target specific pigments or skin conditions. Benefits include non-invasive removal of tattoos and treatment of pigmented lesions and wrinkles. Device is a prescription-only surgical instrument.

Clinical Evidence

No clinical data. Evidence consists of bench testing (electrical safety, EMC, laser safety), biocompatibility (ISO 10993), ex vivo tissue interaction studies, and animal studies to verify mechanism of action.

Technological Characteristics

Solid-state pulsed laser; 1064nm/532nm wavelengths; 250ps pulse duration. Articulated arm delivery. Standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993. Biocompatible user-contacting materials. Standalone system.

Indications for Use

Indicated for tattoo removal (Fitzpatrick I-VI for 1064nm; I-III for 532nm) and treatment of benign pigmented skin lesions (Fitzpatrick I-IV) and wrinkles (Fitzpatrick I-IV) using microbeam handpieces.

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

• PicoWay Laser System (K191685)

Reference Devices

• PICOCARE MAJESTY (K241144)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

January 30, 2026

Boston Aesthetics INC
Cao Hongmei
General manager
1521 Concord Pike Suite 201
Wilmington, Delaware 19803

Re: K251981
Trade/Device Name: Boston PICO (Boston PICO)
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: June 27, 2025
Received: December 31, 2025

Dear Cao Hongmei:

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.

{1}

K251981 - Cao Hongmei
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.

{2}

K251981 - Cao Hongmei
Page 3

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: 2026.01.30
15:34:16'-05'00'

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

{3}

FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251981 | |
| Device Name Boston PICO (Boston PICO) | |
| Indications for Use (Describe) The Boston PICO is indicated for surgical and cosmetic use in dermatology department, general surgery department and plastic surgery department, details are as follows: 1064 nm wavelength: - Remove tattoos of all skin types (Fitzpatrick skin type I-VI) in the following colors: black, brown, green, blue and purple. - Treat benign pigmented skin lesions of Fitzpatrick I-IV types. 532 nm wavelength: - Remove tattoos of Fitzpatrick skin type I-III in the following colors: red, yellow and orange. - Treat benign pigmented skin lesions of Fitzpatrick I-IV types. Microbeam handpieces (1064nm and 532nm) are used for the treatment of wrinkles for skin types I-IV. | |
| 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "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." | |

{4}

510(k) Summary
#K251981

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of 21 CFR §807.92.

## 1. Administrative Information

### Preparation Date
2026-01-29

### Submission Correspondent
Name: Boston Aesthetics INC
Address: 1521 Concord Pike Suite 201 Wilmington DE 19803
Tel: [phone]
E-mail: [e-mail]
Contact: Ms. Hongmei Cao

## 2. Device Information

| Device Name: | Boston PICO |
| --- | --- |
| Model: | Boston PICO |
| Manufacturer: | Boston Aesthetics INC |
| Regulation Description: | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Regulation Number: | 878.4810 |
| Product Code: | GEX |
| Device Class: | 2 |
| Type of 510(k) Submission: | Traditional |

## 3. Predicate Device

| Device name: | PicoWay Laser System |
| --- | --- |
| Manufacturer: | Candela Corporation |
| Regulation Description: | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Regulation Number: | 878.4810 |
| Product code: | GEX |
| Device Class: | 2 |
| 510(K) Number: | K191685 |

Page 1 of 6

{5}

Page 2 of 6

# 4. Reference Device

| Device name: | PICOCARE MAJESTY |
| --- | --- |
| Manufacturer: | WonTech Co., Ltd. |
| Regulation Description: | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Regulation Number: | 878.4810 |
| Product code: | GEX |
| Device Class: | 2 |
| 510(K) Number: | K241144 |

# 5. Intended Use/Indication for Use

The Boston PICO is indicated for surgical and cosmetic use in dermatology department, general surgery department and plastic surgery department, details are as follows:

1064 nm wavelength:
- Remove tattoos of all skin types (Fitzpatrick skin type I-VI) in the following colors: black, brown, green, blue and purple.
- Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

532 nm wavelength:
- Remove tattoos of Fitzpatrick skin type I-III in the following colors: red, yellow and orange.
- Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

Microbeam handpieces (1064nm and 532nm) are used for the treatment of wrinkles for skin types I-IV.

# 6. Device Description

The Boston PICO is a multi-wavelength, pulsed laser system, and a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in 250ps(± 20%). The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed. The 1064 nm wavelength can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.

{6}

7. Comparison with predicate device

| Items | Subject Device | Predicate device (K191685) | Reference Device (K241144) | Comparison |
| --- | --- | --- | --- | --- |
| Name | Boston PICO | PicoWay Laser System | PICOCARE MAJESTY | / |
| Model | Boston PICO | / | / | / |
| Type of use | Prescription Use | Prescription Use | Prescription Use | Same |
| Anatomical Site | Skin and subcutaneous tissue | Skin and subcutaneous tissue | Skin and subcutaneous tissue | Same |
| Handpiece | Zoom handpiece (1064nm, 532nm)
1064 handpiece (1064nm)
1064x handpiece (1064nm)
532 handpiece (532nm)
532x handpiece (532nm) | Zoom handpiece(532nm, 1064 nm)
Resolve handpiece(1064nm)
Resolve High energy handpiece (532nm) | Zoom(1064nm, 532nm)
DOE (1064nm, 532nm) | Comparable |
| Wavelength | 1064nm; 532nm | 1064nm; 532nm | 1064nm; 532nm | Same |
| Pulse Duration | 250ps | 240-500ps | 275~300ps | Comparable |
| Max pulse energy | Zoom(1064): 500mJ
Zoom(532): 250mJ
1064, 1064x: 400 mJ
532, 532x: 200mJ | Zoom(1064): 400mJ
Zoom(532): 200mJ
Resolve 1064: 290mJ
Resolve High Energy(532nm): 150mJ | Zoom(1064): 500mJ
Zoom(532): 250mJ
DOE (1064nm): 450mJ
DOE (532nm): 200mJ | Comparable |
| Fluence | Zoom(1064nm): 0.12~15.7J/cm²
Zoom(532nm): 0.06~7.6 J/cm²
1064, 1064x: 0.1~4.0 mJ/MTZ
532, 532x: 0.1~ 2.0 mJ/MTZ | Zoom(1064): 0.20-12.5J/cm²
Zoom(532): 0.16-6.25J/cm²
Resolve 1064: 0.5-2.9 mJ/ubeam
Resolve High Energy(532nm): 0.2-1.6mJ/ubeam | Zoom(1064): 0.2 ~ 10.0 J/cm²
Zoom(532): 0.1 ~ 2.5 J/cm²
DOE (1064nm): 0.4 ~ 5.5 mJ/μbeam
DOE (532nm): 0.25 ~ 2.5 mJ/μbeam | Comparable |
| Max pulse power | Zoom(1064): 2.0 GW
Zoom(532): 1.0 GW
1064, 1064x: 1.6 GW
532, 532x: 0.8 GW | Zoom(1064): 0.9 GW (400 mJ)
Zoom(532): 0.5 GW (200 mJ)
Resolve 1064: 0.64 GW
Resolve High Energy(532nm): 0.33 GW | Zoom(1064): 2.0 GW
Zoom(532): 1.3 GW
DOE (1064nm): 1.8 GW
DOE (532nm): 1.05 GW | Comparable |
| Repetition Rate | Single, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 Hz | Single, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 Hz | Single, 1 ~ 10 Hz | Same |

{7}

| Items | Subject Device | Predicate device (K191685) | Reference Device (K173700) | Comparison |
| --- | --- | --- | --- | --- |
| Spot Size | Zoom: 2 mm - 10 mm
1064x: 10mm×10mm
1064: 6mm×6mm
532x: 10mm×10mm
532: 6mm×6mm | Zoom: 2 mm - 10 mm
Resolve 1064: 6mm×6mm
Resolve High Energy(532nm): 6mm×6mm | Zoom: 2 mm - 10 mm
DOE (1064nm): 9mm×9mm
DOE (532nm): 9mm×9mm | Comparable |
| Aiming Beam | Wavelength:620nm - 670nm, unadjustable
Optical power: < 5mW | Wavelength: 650nm. ±20%, unadjustable
Optical power: < 3.5mW | Not Publicly Available | Comparable |
| System dimension | 1000x400x1200(mm) (L×W×H)
Not including light guide articulated arm | 1090x408x763(mm)
Height does not include articulated arm | Not Publicly Available | Comparable |
| Weight | About 100kg | About 122kg | About 99kg | Comparable |
| Rated voltage and power | 110-220 VAC; 10A; 50/60 Hz
Input power rate: 2500VA | 200-240 VAC; 50/60 Hz; 30A
4600 VA, single phase | 200-240 VAC, 50/60 Hz, 4.0kVA | Comparable |

The subject device and the predicate device have the same intended use. Although the subject device and the predicate device have several different technological characteristics as noted in the table above, the differences do not raise different questions of safety and effectiveness. Therefore, we consider that the subject device is as safe and effective as the predicate device

{8}

Page 5 of 6

# 8. Non-Clinical Performance Testing

## 8.1. Electromagnetic Compatibility and Electrical Safety Test

The subject device has passed safety testing in according to following standards.

1) IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
2) 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
3) IEC 60825-1: 2014 Safety of laser products - Part 1: Equipment classification and requirements
4) IEC 60601-1-2:2014 + A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances- Requirements and tests
5) IEC TS 60601-4-2: 2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

## 8.2. Biocompatibility Test

Biocompatibility testing was conducted in accordance with the 2020 FDA guidance “Use of International Standard ISO 10993, Biological Evaluation of Medical Device Part 1: Evaluation and Testing.” The testing includes:

1) Cytotoxicity per ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity.
2) Sensitization per ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
3) Irritation per ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
4) Systemic toxicity per ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

The user- contacting materials were shown to be non-cytotoxic, non-irritating and non-sensitizing.

## 8.3. Performance test

The proposed device meet the specification and performance characteristics as identified in design control procedures and are substantially equivalent to the predicate device. The performance tests of the subject device which were conducted included but not limited to laser wavelength, pulse width, terminal maximum single pulse energy, maximum pulse power, repeat pulse frequency, treatment spot diameter, treatment energy and treatment energy intensity. All the test results meet the acceptance criteria.

## 8.4 Software verification and validation

Software documentation of the subject device was provided in accordance with the FDA guidance Document- “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff”, which was issued in 06/14/2023 to support a device’s Basic

Documentation Level.

{9}

Page 6 of 6

## 8.5 In vitro testing

Ex vivo testing of the Boston PICO with different handpieces was conducted to evaluate the mechanism by which the device interacts with tissue, as well as its safety and effectiveness, without involving a complete living system.

## 9. Animal testing

Animal studies allow simulation of in vivo treatment conditions to verify the mechanism of action of the Boston PICO device on biological tissues, and to evaluate its safety and effectiveness under actual use conditions.

## 10. Clinical data

No clinical study is included in this submission.

The Substantial equivalence does not depend on the clinical test data.

## 11. Conclusion

The subject device and the predicate device have the same intended use and any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness. The results of the testing described above demonstrate that the subject device is as safe and effective as the predicate device (K191685) and supports a determination of substantial equivalence.