Mobay (Bayer) Merlon M-40 (H)F 1112
FDA 510(k) K873822 · Applied Laboratories, Inc.
510(k) numberK873822
Submission
- Device name
- Mobay (Bayer) Merlon M-40 (H)F 1112
- Applicant
- Applied Laboratories, Inc.
Columbus, IN, US - Received
- September 21, 1987
- Decision date
- March 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRX – Case, Contact Lens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5928
- Specialty
- Ophthalmic
Other 510(k)s with product code LRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252175 | LANDR Contact LENS CaseLRX · Traditional | Fourth Axis, LLC | 02/10/2026SE |
| K250495 | Mini VP1 (PL67_F); Mini VP1 (PL61_F)LRX · Traditional | Avizor S.A. | 08/01/2025SE |
| K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)LRX · Traditional | Shanghai Care US Medical Product Co., Ltd. | 10/09/2024SE |
| K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case -…LRX · Traditional | Phoenix Innovative Healthcare Manufacturers Pvt.… | 08/30/2023SE |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscLRX · Special | Alcon Laboratories, Inc. | 12/04/2017SE |
| K172925 | Contact Lens Case, Model: A-1, B-1LRX · Traditional | P L Overseas Limited | 11/30/2017SE |
| K173365 | Bausch + Lomb Boston Scleral Lens CaseLRX · Traditional | Bausch & Lomb, Incorporated | 11/17/2017SE |
| K171539 | Contact Lens CaseLRX · Traditional | E-Link Plastic & Metal Industrial Co.,Ltd | 07/14/2017SE |
| K171163 | Contact Lens Case Round GlassesLRX · Traditional | Fiftytwoways, Ltd. | 06/27/2017SE |
| K162869 | Contact Lens CaseLRX · Traditional | Ningbo Yinzhou Zonghai Artware Co., Ltd. | 12/09/2016SE |
More from Ningbo Yinzhou Zonghai Artware Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K873825 | GE Lexan 144R 112LRX · Traditional | 03/24/1988SE |
| K873824 | Red #467, #457, Blue #437, Green #447 Mindel S1000LRX · Traditional | 03/24/1988SE |
| K873823 | Mobay (Bayer) Makrolon 2658 3291LRX · Traditional | 03/24/1988SE |
| K873821 | GE Noryl 731-80089SLRX · Traditional | 03/24/1988SE |
| K873820 | Mobay (Bayer) Makrolon 2658 1112LRX · Traditional | 03/24/1988SE |
| K871714 | Kestrel Contact Lens CaseLPN · Traditional | 05/26/1987SE |
| K860677 | Easy Eyes TM Lens Carrying CaseHPX · Traditional | 05/29/1986SE |
| K853870 | Easy Eyes TM Lens Carrying CaseHPX · Traditional | 12/10/1985SE |
Questions and answers
When was Mobay (Bayer) Merlon M-40 (H)F 1112 cleared by the FDA?
Mobay (Bayer) Merlon M-40 (H)F 1112 (K873822) received a 510(k) decision of Substantially Equivalent on March 24, 1988, 185 days after the submission was received.
What is the product code of K873822?
The FDA product code is LRX – Case, Contact Lens, a Class II (moderate risk) device regulated under 21 CFR 886.5928.