The Alma Opus System, Colibri Applicator and Tips
FDA 510(k) K201520 · Alma Lasers, Inc.
510(k) numberK201520
Submission
- Device name
- The Alma Opus System, Colibri Applicator and Tips
- Applicant
- Alma Lasers, Inc.
Buffalo Grove, IL, US - Received
- June 8, 2020
- Decision date
- October 27, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K251684 | Alma TED+ SystemOAP · Traditional | 06/05/2026SE |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesGEX · Traditional | 09/24/2025SE |
| K251230 | The Alma Hybrid Laser SystemGEX · Special | 05/21/2025SE |
| K243044 | Alma HarmonyGEX · Traditional | 04/11/2025SE |
| K233024 | Alma HarmonyGEX · Traditional | 02/08/2024SE |
| K230308 | Alma HarmonyGEX · Traditional | 03/01/2023SE |
| K230371 | The Alma Soprano TitaniumGEX · Special | 02/22/2023SE |
| K222064 | The Alma Soprano TitaniumGEX · Traditional | 10/12/2022SE |
| K212073 | Alma Diode Tabletop LaserGEX · Traditional | 07/14/2022SE |
| K203441 | The Alma Hybrid Laser SystemGEX · Traditional | 07/02/2021SE |
Questions and answers
When was The Alma Opus System, Colibri Applicator and Tips cleared by the FDA?
The Alma Opus System, Colibri Applicator and Tips (K201520) received a 510(k) decision of Substantially Equivalent on October 27, 2021, 506 days after the submission was received.
What is the product code of K201520?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.