510(k) K250402
- Device
- AVAVA™ Skin Treatment System
- Applicant
- AVAVA, Inc.
- 510(k) number
- K250402
- Product code
- ONG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-14
- Date received
- 2025-02-12
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument With MicrobeamFractional Output
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Richard Bankowski
- Address
- 275 2nd Ave. 3rd Floor Waltham MA US 02451 02451
FDA Registration Numbers#
- 3023808190
- 3006985163
- 1222993
- 3014737458
- 3009736547
- 3043047259
- 3011555967
- 3021349626
- 3014388884
- 3037874486
- 3033511105
- 3017132875
- 3033715699
- 3013789508
- 3006247712
- 3005238200
- 3015452693
- 3008442971
- 3013602304
- 3025181200
- 3007712511
- 3030230686
- 3006555617
- 3043657394
- 1313525
- 3006716777
- 3012639861
- 3009040934
- 3006680097
- 2953696
- 3007120647
- 3004167969
- 3010902869
- 3016661372
- 3014144061
- 3033524191
- 3001431138
- 3017125161
- 3021550489
- 3015983416
- 3004710757
- 3031233197
- 3004483538
- 3015218136
- 3007867838
- 3036240802
- 3003899230
- 3014310779
- 9680671
- 3010363436
- 1226486
- 2027755
- 2953684
- 3011423170
- 9613462
- 3007549439
- 3004633032
Source Documents#
Other 510(k) Records For Product Code ONG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252155 | AVAVA™ Skin Treatment System | AVAVA, Inc. | 2025-10-20 |
| K244060 | eCO2 3D | Lutronic Corporation | 2025-07-31 |
| K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. | 2025-07-02 |
| K233550 | MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic | 2024-01-02 |
| K223871 | Miria Skin Treatment System | AVAVA, Inc. | 2023-06-22 |
| K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | 2022-11-21 |
| K221770 | Fiber Laser Treatment System | Shanghai Apolo Medical Technology Co., Ltd. | 2022-10-13 |
| K213332 | Multifrax Laser System | Paradigm Medical Corporation | 2022-06-03 |
| K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021-04-13 |
| K192350 | Medical Non-Ablative Fractional Laser Systems | Wingderm Electro-Optics , Ltd. | 2020-04-30 |
| K182498 | Advanced Skin Renewing Device | Jiangsu Unimed Laser Technology Co., Ltd. | 2018-11-30 |
| K180036 | SMAXEL CO2 Surgical Laser System | Ids, Ltd. | 2018-02-02 |
| K162398 | CO2 Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | 2017-07-06 |
| K141868 | TRIA FANP | Tria Beauty, Inc. | 2014-12-30 |
| K141046 | MIDI-SRS | Srmc Co., Ltd. | 2014-12-24 |