Documenting Laser Slit Lamp, DP 2010
FDA 510(k) K012873 · Bausch & Lomb, Inc.
510(k) numberK012873
Submission
- Device name
- Documenting Laser Slit Lamp, DP 2010
- Applicant
- Bausch & Lomb, Inc.
Irvine, CA, US - Received
- August 27, 2001
- Decision date
- November 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HJO – Biomicroscope, Slit-Lamp, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
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| K171877 | SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional | Chongqing Kanghua Ruiming S&T Co., Ltd. | 12/21/2017SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 10/06/2017SE |
| K162778 | Portable Slit Lamp MicroscopeHJO · Traditional | Suzhou Kangjie Medical, Inc. | 07/21/2017SE |
| K162684 | SL 220HJO · Traditional | Carl Zeiss Meditec, AG | 05/31/2017SE |
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Questions and answers
When was Documenting Laser Slit Lamp, DP 2010 cleared by the FDA?
Documenting Laser Slit Lamp, DP 2010 (K012873) received a 510(k) decision of Substantially Equivalent on November 19, 2001, 84 days after the submission was received.
What is the product code of K012873?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.