510(k) K142717
- Device
- Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
- Applicant
- Ni Hau Industrial Co., Ltd.
- 510(k) number
- K142717
- Product code
- LRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-05-07
- Date received
- 2014-09-23
- Regulation
- 886.5928
- Classification name
- Case, Contact Lens
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lyn Chiu
- Address
- # 15, Aly. 125, Ln. 318, Section 2, An Ho Rd. Tainan City TW 70967 70967
FDA Registration Numbers#
- 3013875449
- 1419844
- 3003515967
- 1000375210
- 8043685
- 3010612624
- 3044227206
- 3037650313
- 3006633372
- 3014254835
- 3004388281
- 3006542501
- 3012603529
- 9710641
- 2183416
- 9614761
- 3006218807
- 2085143
- 2432426
- 3010700223
- 1610287
- 3009648765
- 3003559457
- 3003062331
- 3013398957
- 8022656
- 2936829
- 3006112861
- 3010408344
- 3003306559
- 3009694272
- 1063410
- 1937310
- 3007186430
- 1218954
- 1313525
- 3006140792
- 3012316249
- 3010413909
- 3011046360
- 3004270595
- 3015146495
- 3013433228
- 3013499648
Source Documents#
Other 510(k) Records For Product Code LRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252175 | LANDR Contact LENS Case | Fourth Axis, LLC | 2026-02-10 |
| K250495 | MINI VP1 (PL67_F); MINI VP1 (PL61_F) | Avizor S.A. | 2025-08-01 |
| K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | Shanghai Care US Medical Product Co., Ltd. | 2024-10-09 |
| K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | 2023-08-30 |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2017-12-04 |
| K172925 | Contact Lens Case, Model: A-1, B-1 | P L Overseas Limited | 2017-11-30 |
| K173365 | Bausch + Lomb Boston Scleral Lens Case | Bausch & Lomb, Incorporated | 2017-11-17 |
| K171539 | Contact Lens Case | E-Link Plastic & Metal Industrial Co.,Ltd | 2017-07-14 |
| K171163 | Contact Lens Case Round Glasses | Fiftytwoways, Ltd. | 2017-06-27 |
| K162869 | Contact Lens Case | Ningbo Yinzhou Zonghai Artware Co., Ltd. | 2016-12-09 |
| K160005 | Contact Lens Case (multiple brand name) | Danyang Chanxin Glasses Cases Factory | 2016-06-07 |
| K143351 | iCase Contact Lens Case | Novabay Pharmaceuticals, Inc. | 2015-04-29 |
| K140488 | CONTACT LENS CASE | Maca Plastics, Inc. | 2014-09-10 |
| K131783 | POLAROID CONTACTSPOD | Viopti, Ltd. | 2014-02-21 |
| K130930 | OWL CONTACT LENS CASES, DOG CONTACT LENS CASES | Ningbo Lishunda Electronics Co., Ltd. | 2014-02-12 |
Legacy Summary#
summary
FDA Review#
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