Q-Switched Nd: YAG Laser Systems

K260256 · Shanghai Apolo Medical Technology Co., Ltd. · GEX · May 4, 2026 · General, Plastic Surgery

Device Facts

• Record ID: K260256
• Device Name: Q-Switched Nd: YAG Laser Systems
• Applicant: Shanghai Apolo Medical Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 4, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Q-Switched Nd: YAG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows: 532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585nm and 650nm with optional dye handpieces): - Removal of light ink (red, sky blue, green, purple, and orange) tattoo, - Treatment of benign vascular lesions including, but not limited to: telangiectasias, - Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses, - Treatment of Post Inflammatory Hyper-Pigmentation, - Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064nm in nanosecond mode (with QS, Q-PTP, Q-3, Q-4 function), including microbeam handpieces: - Removal dark ink (black, blue and brown) tattoo, - Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma, - Removal or lightening of unwanted hair with or without adjuvant preparation, - Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064nm in SPT mode: - Treatment of wrinkles, - Treatment of mild to moderate inflammatory acne vulgaris. 1064nm in LPS (Long pulse) mode: - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin, - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins, - Coagulation and hemostasis of soft tissue, - Treatment of wrinkles and acne vulgaris.

Device Story

Q-Switched Nd:YAG laser system (models HS-290, HS-290E) for dermatological procedures. System components: laser generator, articulated arm, power supply, cooling system, display/control system, foot switch. Inputs: electrical power; operator-selected settings (wavelength, mode, energy, repetition rate). Operation: generates pulsed coherent light at 1064nm and 532nm (convertible to 585nm/650nm via dye handpieces). Delivery: articulated arm with zoom, microbeam, collimated, or long-pulse handpieces. Used in clinical settings by trained professionals. Output: laser energy applied to target tissue for ablation, coagulation, or pigment destruction. Clinical benefit: removal of tattoos/lesions, hair reduction, skin resurfacing, and hemostasis.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and performance validation against recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).

Technological Characteristics

Nd:YAG laser generator; 532nm/1064nm wavelengths; Q-Switched, SPT, and LPS modes. Articulated arm delivery with zoom, microbeam, collimated, and long-pulse handpieces. Energy source: electrical. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. System includes display/control interface and cooling system.

Indications for Use

Indicated for patients requiring tattoo removal, treatment of benign vascular/pigmented lesions, soft tissue incision/excision/ablation/vaporization, hair removal, and treatment of acne/wrinkles. Applicable to all Fitzpatrick skin types I-VI. Contraindications not specified.

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

• Q-Switched Nd: YAG Laser System (K190936)
• HOLLYWOOD SPECTRA Laser System (K213569)
• Finebeam (K202288)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 4, 2026

Shanghai Apolo Medical Technology Co., Ltd.
Felix Li
RA Supervisor
Bldg. 11, Lane 1566, Nanle Rd., Songjiang District
Shanghai, 201613
China

Re: K260256
Trade/Device Name: Q-Switched Nd: YAG Laser Systems (HS-290, HS-290E)
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: January 27, 2026
Received: January 28, 2026

Dear Felix Li:

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.

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

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K260256 - Felix Li
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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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K260256 - Felix Li
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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: 2026.05.04
14:48:27 -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.

510(k) Number (if known)
K260256

Device Name
Q-Switched Nd: YAG Laser Systems (HS-290, HS-290E)

Indications for Use (Describe)
The Q-Switched Nd: YAG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585nm and 650nm with optional dye handpieces):
- Removal of light ink (red, sky blue, green, purple, and orange) tattoo,
- Treatment of benign vascular lesions including, but not limited to: telangiectasias,
- Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses,
- Treatment of Post Inflammatory Hyper-Pigmentation,
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064nm in nanosecond mode (with QS, Q-PTP, Q-3, Q-4 function), including microbeam handpieces:
- Removal dark ink (black, blue and brown) tattoo,
- Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma,
- Removal or lightening of unwanted hair with or without adjuvant preparation,
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064nm in SPT mode:
- Treatment of wrinkles,
- Treatment of mild to moderate inflammatory acne vulgaris.

1064nm in LPS (Long pulse) mode:
- Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin,
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins,
- Coagulation and hemostasis of soft tissue,
- Treatment of wrinkles and acne vulgaris.

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.

FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services [phone]

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FORM FDA 3881 (8/23)

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| 510(k) #: K260256 | 510(k) Summary | Prepared on: 2026-05-01 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Shanghai Apolo Medical Technology Co., Ltd. | |
| Applicant Address | Building 11, Lane 1566, Nanle Road, Songjiang District Shanghai Shanghai 201613 China | |
| Applicant Contact Telephone | [phone] | |
| Applicant Contact | Mr. Felix Li | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Q-Switched Nd: YAG Laser Systems (HS-290, HS-290E) | |
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology | |
| Classification Name | Powered Laser Surgical Instrument | |
| Regulation Number | 878.4810 | |
| Product Code(s) | GEX | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K190936 | Q-Switched Nd: YAG Laser System | GEX |
| K213569 | HOLLYWOOD SPECTRA Laser System | GEX |
| K202288 | Finebeam | GEX |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Q-Switched Nd: YAG Laser Systems (HS-290, HS-290E) is based on the Q-Switch Nd: YAG and frequency-double Nd:YAG laser technology. The system is composed of laser generator, articulated arm, laser power supply, cooling system, display and control system, foot switch and other accessories. The Q-Switched Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a zoom handpiece, microbeam handpiece, collimated handpiece and long pulse handpiece. In addition, two dye handpieces are available that concert the 532nm wavelength to 585nm and 650nm. The Q-Switched Nd: YAG Laser System includes two models: HS-290 and HS-290E. The difference between the two models is the appearance dimension. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| The Q-Switched Nd: YAG Laser Systems (HS-290, HS-290E) is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows: 532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585nm and 650nm with optional dye | | |

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handpieces):
- Removal of light ink (red, sky blue, green, purple, and orange) tattoo,
- Treatment of benign vascular lesions including, but not limited to: telangiectasias,
- Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses,
- Treatment of Post Inflammatory Hyper-Pigmentation,
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064nm in nanosecond mode (with QS, Q-PTP, Q-3, Q-4 function), including microbeam handpieces:
- Removal dark ink (black, blue and brown) tattoo,
- Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma,
- Removal or lightening of unwanted hair with or without adjuvant preparation,
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064nm in SPT mode:
- Treatment of wrinkles,
- Treatment of mild to moderate inflammatory acne vulgaris.

1064nm in LPS (Long pulse) mode:
- Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin,
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins,
- Coagulation and hemostasis of soft tissue,
- Treatment of wrinkles and acne vulgaris.

**Indications for Use Comparison** 21 CFR 807.92(a)(5)

The indications for use of the proposed device are the same as the predicate devices.

**Technological Comparison** 21 CFR 807.92(a)(6)

Q-switched and SPT mode:

The wavelengths (532nm, 1064nm) of the subject device are the same as the predicate devices K190936, K213569.

The maximum output energy of zoom handpiece (532nm/1064nm Q-Switched mode) is 500mJ and 1200mJ respectively and is the same as predicate device K190936. The maximum output energy of zoom handpiece (1064nm Q-PTP) is 1200mJ, which is covered by the predicate device K213569 (1400mJ). The maximum output energy of zoom handpiece (1064nm Q-3, Q-4) is 1400mJ, which is the same as the predicate device K213569. The maximum output energy of zoom handpiece (1064nm SPT mode) is 1400mJ, which is the same as predicate device K190936 (1400mJ) and covered by predicate device K213569 (1500mJ, Spectra mode). The maximum output energy of collimated handpiece (532nm/1064nm Q-Switched mode) is 400mJ and 1200mJ respectively and is the same as predicate device K213569. The maximum output energy of microbeam handpiece (532nm/1064nm Q-Switched mode) is 400mJ and 1200mJ respectively and is the same as predicate device K213569. The maximum output energy of dye handpiece (585nm/650nm under 532nm Q-Switched mode) is 240mJ and 200mJ respectively and is covered by predicate device K190936 (500mJ, 500mJ).

The pulse duration of the zoom handpiece (532nm/1064nm Q-Switched mode) is 4-6ns, which is the same as the predicate K190936. The pulse duration of the zoom handpiece (1064nm Q-PTP) is 4-6ns, which is similar to the predicate device K213569 (5-10ns), the minor difference does not affect the safety and effectiveness of the device. The pulse duration of the zoom handpiece (1064nm Q-3, Q-4) is 8-12ns, which is similar to the predicate device K213569 (10-20ns), the minor difference does not affect the safety and effectiveness of the device. The pulse duration of the zoom handpiece (1064nm SPT mode) is 300μs, which is the same as the predicate devices K190936 (SPT mode) and K213569 (Spectra mode). The pulse duration of the collimated handpiece (532nm/1064nm Q-Switched mode) is 4-6ns, which is similar to the predicate device K213569 (5-10ns), the minor difference does not affect the safety and effectiveness of the device. The pulse duration of the microbeam handpiece(532nm/1064nm Q-Switched mode) is 4-6ns, which is similar to the predicate device K213569 (5-10ns), the minor difference does not affect the safety and effectiveness of the device. The pulse duration of the dye handpiece (585nm/650nm under 532nm Q-Switched mode) is 4-6ns, which is the same as the predicate K190936.

The maximum repetition rate of zoom handpiece (532nm/1064nm Q-Switched mode) is 10Hz, which is the same as the predicate device K190936. The maximum repetition rate of zoom handpiece (1064nm Q-PTP, Q-3, Q-4) is 10Hz, which is the same as the predicate devices K213569. The maximum repetition rate of zoom handpiece (1064nm SPT mode) is 10Hz, which is the same as the predicate devices K190936 and K213569 (Spectra mode). The maximum repetition rate of collimated/microbeam handpiece (532nm/1064nm Q-Switched

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mode) is 10Hz, which is the same as the predicate devices K213569. The maximum repetition rate of dye handpiece (585nm/650nm under 532nm Q-Switched mode) is 10Hz, which is the same as the predicate device K190936.

The spot size of zoom handpiece (532nm/1064nm Q-Switched mode) is 2-10mm, which is the same as the predicate K190936. The spot size of zoom handpiece (1064nm Q-PTP, Q-3, Q-4) is 2-10mm, which is similar to the predicate device K213569 (2-7mm), the minor difference does not affect the safety and effectiveness of the device. The spot size of zoom handpiece (1064nm SPT mode) is 2-10mm, which is the same as the predicate K190936 and similar to the predicate device K213569 (Spectra mode). The spot size of collimated handpiece (532nm/1064nm Q-Switched mode) is 7mm and 8mm respectively, which is covered by the predicate device K213569 (532nm:2.6, 3.4, 4.3, 5.2, 6.0, 6.9mm, 1064nm:3, 4, 5, 6, 7, 8 mm). The spot size of microbeam handpiece (532nm/1064nm Q-Switched mode) is 7mm and 8mm respectively, which is the same as the predicate device K213569 (532nm: 6.9mm, 1064nm:8 mm). The spot size of dye handpiece (585nm/650nm under 532nm Q-Switched mode) is 2-3mm, which is the same as the predicate device K190936.

LPS mode:

The wavelength (1064nm) of the subject device is the same as the predicate devices K202288 (LPS mode).

The maximum output energy of long pulse handpiece (1064nm LPS mode) is 60J and is the same as predicate device K202288.

The pulse duration of long pulse handpiece (1064nm LPS mode) is 5-150ms, which is within the range of the predicate device K202288 (0.5-300ms).

The repetition rate of long pulse handpiece (1064nm LPS mode) is 1-5Hz, which is covered by the predicate device K202288 (1-10Hz).

The spot size of long pulse handpiece (1064nm LPS mode) is 6-10mm, which is within the range of the predicate device K202288 (2-10mm).

## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

### Non-Clinical Testing:

A battery of tests was performed to verify that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:

- Electrical safety and electromagnetic compatibility
- IEC 60601-1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 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
- IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for the 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

### Clinical Testing:

It is not applicable.

### Conclusions:

Base on the performance testing and validation studies that the subject device is substantially equivalent to the predicate device.