Bclear
FDA 510(k) K021762 · Lumenis, Inc.
510(k) numberK021762
Submission
- Device name
- Bclear
- Applicant
- Lumenis, Inc.
Pleasanton, CA, US - Received
- May 29, 2002
- Decision date
- August 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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| K230382 | 3 Series NeoLuxFTC · Special | Daavlin Distributing Co. | 03/24/2023SE |
| K230076 | Enhanced AURORA Medical Diode System, and related accessoriesFTC · Traditional | Psoria-Shield, Inc. | 03/08/2023SE |
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| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityGEX · Traditional | 09/18/2017SE |
| K170060 | M22 and ResurFx SystemsGEX · Special | 08/09/2017SE |
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Questions and answers
When was Bclear cleared by the FDA?
Bclear (K021762) received a 510(k) decision of Substantially Equivalent on August 23, 2002, 86 days after the submission was received.
What is the product code of K021762?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.